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About 369,505 results

Gocovri Clinical Data
https://www.gocovrihcp.com/clinical-data/
Gocovrihcp.com

May 28th, 2020 - The efficacy and safety of GOCOVRI® 274 mg were evaluated in two Phase 3, randomized, placebo-controlled trials

FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma
https://www.fda.gov/drugs/fda-approves-brexucabtagene-autoleucel-relapsed-or-refractory-mantle-cell-lymphoma
FDA

Jul 24th, 2020 - The Food and Drug Administration granted accelerated approval to brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company), a CD19-directed genetically modified autologous T cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Fluconazole - fluconazole tablet-REMEDYREPACK INC.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d11e0926-cd15-49ba-b0ee-2b6d4e009dd8

Dec 30th, 2022 - Fluconazole tablets are indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to Candida). Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, di...

Lorzone - chlorzoxazone tablet-Vertical Pharmaceuticals, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bdd61b83-5bcd-4d23-8ef5-aeb9ca2f7c14

Dec 1st, 2022 - Lorzone ® is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.

Chlorzoxazone - chlorzoxazone tablet-Trigen Laboratories, LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=60b6456f-2292-7ea4-e053-2a91aa0a9b37

Dec 1st, 2022 - Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.

Gocovri Prescribing Information
https://www.gocovrihcp.com/pdf/Gocovri_Prescribing_Information.pdf

Gocovri Prescribing Information, PI, Parkinson Disease, PD

Remdesivir Clinical Trials
https://www.gilead.com/purpose/advancing-global-health/covid-19/remdesivir-clinical-trials

The remdesivir clinical trial program was designed to answer multiple scientific questions in parallel, to rapidly evaluate the potential for remdesivir to treat COVID-19 patients.

U.S. FDA Approves Evofem Biosciences' Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy
https://evofem.investorroom.com/2020-05-22-U-S-FDA-Approves-Evofem-Biosciences-Phexxi-TM-lactic-acid-citric-acid-and-potassium-bitartrate-the-First-and-Only-Non-Hormonal-Prescription-Gel-for-the-Prevention-of-Pregnancy

Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Ascor - ascorbic acid injection-McGuff Pharmaceuticals, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388aad52-fc01-4784-9791-1dbc80c69306

Oct 1st, 2022 - ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. ASCOR is vitamin C indicated for the short...

Esomeprazole sodium - esomeprazole sodium injection, powder, lyophilized, for solution-Hainan Poly Pharm. Co., Ltd.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6635546-be95-4df0-b311-c6d74a4258e7

Aug 8th, 2022 - Esomeprazole sodium for injection is a proton pump inhibitor (PPI) indicated for the: Short-term treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis (EE) in adults and pediatric patients 1 month to 17 years of age, as an alternative to oral therapy when oral esomeprazole is not possible or appropriate. (1.1) Risk reduction of rebleeding of gastric or duodenal ulcers fol...

FDA updates Sotrovimab emergency use authorization
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization
US Food and Drug Administration (FDA)

Apr 5th, 2022 - Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant

U.S. FDA Grants Priority Review to Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults
https://www.gene.com/media/press-releases/14948/2022-04-03/us-fda-grants-priority-review-to-genente
Genentech

Apr 3rd, 2022 - If approved, Actemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalized patients Since the beginning of the pandemic, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide Actemra was previously granted Emergency Use Authorization for the treatment of COVID-19 in hospitalized adults and children

Bimatoprost - bimatoprost solution/ drops-Lupin Pharmaceuticals, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac853f64-50bd-4bff-9cbe-aac93ef5550f

Jul 1st, 2022 - Bimatoprost ophthalmic solution, 0.03% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. (1) Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Aldara - imiquimod cream-Bausch Health US LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c3aed27-7b3f-442e-9f60-f2f5c672c85d

Jun 30th, 2022 - ALDARA Cream is indicated for the topical treatment of: •Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adults. (1.1) •Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults; maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical me...

ONUREG® (azacitidine) for Acute Myeloid Leukemia (AML)
https://www.onuregpro.com/

Learn about an FDA-approved continued treatment option for patients with AML in remission. Register to receive updates. See safety info & full Prescribing Info.

Now Approved PHESGO™‎
https://www.phesgo.com/hcp.html

Info on PHESGO™(pertuzumab/trastuzumab/hyaluronidase-zzxf), See Safety & Boxed Warning. Newly Approved Treatment · Get Info on Dosing · Downloads Available Types: Prescribing Info, Product Guide, Downloadable Brochure

VEKLURY® (remdesivir) - FDA Approved
https://www.vekluryhcp.com/

Learn More About VEKLURY® as an FDA Approved Treatment Option for Eligible Patients. Product Access Information and Resources for HCPs are Available Here. Product Access. Register for Updates. Dosing & Administration. HCP Resources. Patient Support for HCPs.

XYWAV™ Coming Soon - Treatment Information
https://xywav.com/hcp/

(Calcium, Magnesium, Potassium & Sodium Oxybates). See Prescribing Info and BOXED Warning. Discover XYWAV Coming Soon. Sign Up To Receive Treatment and Safety Information Today. Availability Updates. Sign Up. Safety Information. Medication Guide.

XARACOLL | Innocoll Pharmaceuticals - Innocoll.com
https://xaracoll.com/

To Learn More, Visit XARACOLL.com · A portfolio company of. Gurent Point Capital. Innocoll Logo. Business Development Group Unit 9, Block D Monksland ...

Find Safety, PI, Boxed Warning - Now Approved - HCP Site‎
https:// www.oriahnnhcp.com/

ORIAHNN® (elagolix/estradiol/norethindrone acetate and elagolix). View Dosing Information. View Safety Information. Financial Support Info. Official HCP Site.

The Birth Of Something New - BREZTRI AEROSPHERE™
https://breztrihcp.com/

(budesonide/glycopyrrolate/formoterol fumarate) Now Approved. Visit The Physician Site. Explore A New Approved Treatment Option. Be The First To Learn About BREZTRI. Now Approved. Prescribing Information. Register For Updates. Learn The Pronunciation.

MYCAPSSA® (octreotide) Oral - Capsules Is Now FDA-Approved‎
https://hcp.mycapssa.com/

MYCAPSSA® (octreotide) delayed-release oral capsules is the first and only FDA-approved oral somatostatin analog (SSA) for appropriate patients with acromegaly, providing effective and consistent biochemical control, while freeing patients from the burden of injections.

CYSTADROPS (cysteamine ophthalmic solution) 0.37%
https://www.cystadrops.com/

CYSTADROPS (cysteamine ophthalmic solution) 0.37% is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

Dojolvi™ (triheptanoin) oral liquid | Ultragenyx
https://www.dojolvi.com/

Dojolvi is indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).

Evrysdi™ (risdiplam) - Healthcare Professionals Site
https://www.evrysdi-hcp.com/

Visit Official HCP Site to See if Evrysdi™ Could be an Option for Your Patients. Evrysdi Challenges. Evrysdi Education. Evrysdi Resources. Evrysdi Treatment. Types: Learn About Evrysdi, Clinical Trial Results, Safety and Efficacy, Potential Benefits.

Blenrep - Official HCP Website - View Prescribing Information
https://www.blenrephcp.com/

HCPs - Learn About Now Approved BLENREP (belantamab mafodotin-blmf). View Boxed Warning.

ENSPRYNG™ (satralizumab-mwge) - New FDA Approved...
https://www.enspryng-hcp.com

Explore ENSPRYNG™ As A New Treatment Option For Your Patients. Contraindications. Prescribing Information. Safety Info. Dosing & Admin. Types: Financial Assistance, ENSPRYNG Access Solutions, Clinical Trial Data, Patient Resources.

FINTEPLA® (fenfluramine) oral solution, CIV | For Dravet ...
https://www.finteplahcp.com/

FINTEPLA is a prescription medicine used to treat the seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA is a federally controlled substance (C-IV) because it contains fenfluramine. Keep FINTEPLA in a safe place to prevent misuse, abuse, and protect it from theft.

KALYDECO® (ivacaftor) - For Healthcare Professionals
https://www.kalydecohcp.com/

Helpful information for your patients. Get product information intended for healthcare professionals. Resources. About KALYDECO. Studies and Data.

Gimoti™ (metoclopramide) - Nasal Spray‎
https://www.gimotirx.com/

Learn about FDA-approved Gimoti. See Safety and Boxed Warning. Get updates and read about Gimoti, a different formulation of metoclopramide. Prescribing Information. Press Release. Important Safety Info.

KESIMPTA® (ofatumumab) - Official Physician Website
https://www.hcp.novartis.com/Efficacy

KESIMPTA® is FDA Approved. Download a Start Form Today. Visit Now to Learn More. Access PI and Start Resources for HCPs. Contact Us for Support. Enrollment Support. Official HCP Website. HCP Resources. FDA Approved. KESIMPTA® Safety Info.

INQOVI® (decitabine and cedazuridine) tablets | Now Approved
https://www.inqovi.com/

INQOVI is the first and only oral hypomethylating agent (HMA) indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic ...

MONJUVI™ (tafasitamab-cxix) - Official HCP Website
https://www.monjuvihcp.com/

Learn More About MONJUVI, FDA-approved and Now Available. Visit the Official Site Now. Learn About Treatment. Treatment Calendar. Now Approved.

GAVRETO™ (pralsetinib) - Now FDA Approved - HCP Site
https://gavretohcp.com/

Visit The Official HCP Website for GAVRETO Information. Learn More Today. Safety Information. Registration Form. Patient Services. HCP Information. Patient Support. Dosing Information. Downloadable Resources. Healthcare Professionals. Prescribing Information.

Early indicators: Investigational convalescent plasma is safe for patients with COVID-19
https://newsnetwork.mayoclinic.org/discussion/early-indicators-investigational-convalescent-plasma-is-safe-for-patients-with-covid-19/

Mayo Clinic and collaborators today reported safety data on the first 5,000 hospitalized patients transfused with investigational convalescent plasma as part of the Food and Drug Administration’s national Expanded Access Program (EAP) for COVID-19. The early indicators suggest experimental convalescent plasma is safe in treating severely ill patients. At this time, convalescent plasma is the on...

Qwo™ Is Now FDA Approved - Endo Aesthetics
https://www.Qwo.com/Now/FDA-Approved

Qwo™ (collagenase clostridium histolyticum-aaes) Is Now FDA Approved. Check Out The Press Release & Sign Up For More Information From Endo Aesthetics Today. Official Product Site · Sign Up For Updates · Indication

FDA-Approved Treatment - TECARTUS™ - tecartus.com
https://www.tecartus.com/hcp

(Brexucabtagene Autoleucel) Visit Site To Learn More & Read Important Warnings. Download The Medication Guide And Find Your Nearest Treatment Center. Important Warnings. Download Med Guide. Find A Center.

TEPEZZA (teprotumumab-trbw) | Thyroid Eye Disease Treatment
https://www.tepezza.com/hcp/

TEPEZZA is a prescription medicine for the treatment of Thyroid Eye Disease (TED), also known as Graves' Orbitopathy. See safety information.

Zzzquil nighttime sleep-aid - diphenhydramine hydrochloride liquid-The Procter & Gamble Manufacturing Company
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e441c952-cd48-4159-ada2-271ca7541600

Jun 7th, 2022 - for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleepNighttime sleep-aid

Paulas choice clear anti redness exfoliating solution - salicylic acid liquid-Paula's Choice, LLC.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=19ac69ad-d2b7-3aaa-e054-00144ff88e88

Jun 6th, 2022 - OTC - ACTIVE INGREDIENT SECTION Salicylic Acid OTC - PURPOSE SECTION Treats acne Helps clear acne blemishes, blackheads, and whiteheads Helps prevent new acne blemishes DOSAGE & ADMINISTRATION SECTION After cleansing with Paula's Choice Clear Pore Normalizing Cleanser, soak a large cotton ball with Regular Strength Anti-Redness Exfoliating Solution and gently stroke over the face, paying sp...

Moxifloxacin - moxifloxacin solution/ drops-Lupin Pharmaceuticals, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae77e219-8af9-4aa4-96d3-05c9726a1d3c

Jun 6th, 2022 - Moxifloxacin ophthalmic solution, 0.5% is a topical fluoroquinolone anti- infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumonia...

Procentra - dextroamphetamine sulfate solution-Independence Pharmaceuticals, LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1548cce2-fb6b-4f17-8a3b-868933f6c9d6

Jun 1st, 2022 - ProCentra ® (dextroamphetamine sulfate) Oral Solution is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following gr...

Quetiapine fumarate - quetiapine fumarate tablet, extended release-Lupin Pharmaceuticals, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7803a290-91c0-4e7f-90b5-d2ff33a46cee

Jun 1st, 2022 - Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder, manic or mixed episodes (1.2) Bipolar disorder, depressive episodes (1.2) Major depressive disorder, adjunctive therapy with antidepressants (1.3) Quetiapine extended-release tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine ext...

Trazodone hydrochloride - trazodone hydrochloride tablet-Proficient Rx LP
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6c3fb84-5b68-4675-a853-fe49bfbf3f9f

Jun 1st, 2022 - Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).

Imatinib mesylate - imatinib mesylate tablet, film coated-Apotex Corp
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0291eca5-7a1d-4a79-30be-252224d96509

May 30th, 2022 - Imatinib mesylate is a kinase inhibitor indicated for the treatment of: • Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (1.1) • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon...

Lumify redness reliever eye drops - brimonidine tartrate solution/ drops-Bausch & Lomb Incorporated
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=022de945-0b26-40ae-8e88-d3fe2464d106

May 29th, 2022 - •relieves redness of the eye due to minor eye irritationsRedness reliever

Levonorgestrel and ethinyl estradiol - levonorgestrel and ethinyl estradiol kit-Mylan Pharmaceuticals Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=af93fc89-c813-4a8c-9909-44729ab25a64

May 29th, 2022 - Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets are an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1)

Fact Sheet for Patients, Parents, and Caregivers Emergency Use Authorization (EUA) of Bebtelovimab for Coronavirus Disease 2019 (COVID-19)
http://pi.lilly.com/eua/bebtelovimab-eua-factsheet-patient.pdf
Eli Lilly and Company

Feb 11th, 2022 - You are being given this Fact Sheet because your healthcare provider believes it is necessary to provide you or your child with bebtelovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2...

FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR BEBTELOVIMAB
http://pi.lilly.com/eua/bebtelovimab-eua-factsheet-hcp.pdf
Eli Lilly and Company

Feb 11th, 2022 - HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA) These highlights of the EUA do not include all the information needed to use BEBTELOVIMAB under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for BEBTELOVIMAB.

Lilly will supply up to 600,000 doses of bebtelovimab to U.S. government in ongoing effort to provide COVID-19 treatment options
https://investor.lilly.com/news-releases/news-release-details/lilly-will-supply-600000-doses-bebtelovimab-us-government
Eli Lilly and Company

Feb 10th, 2022 - Bebtelovimab neutralizes Omicron as demonstrated by pseudovirus and authentic virus data Patients will continue to have no out-of-pocket costs for the medication

Muro 128 - sodium chloride solution-Bausch & Lomb Incorporated
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=454f337e-d897-46de-ab05-1c543a33061c

May 25th, 2022 - temporary relief of corneal edemaHypertonicity agent

Muro 128 - sodium chloride solution-Bausch & Lomb Incorporated
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cc3d5bc8-9d3c-4c65-9e43-707a2db4081a

May 25th, 2022 - temporary relief of corneal edemaHypertonicity agent

FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls
https://www.fda.gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls
MedWatch; FDA

May 20th, 2022 - UPDATE: On May 19, 2022, the FDA updated this web page to help ensure patients and providers have important information about the recall of these critical devices. See What the FDA is Doing for more information. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive a...

Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Reca...
https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due
MedWatch; FDA

May 20th, 2022 - UPDATE: On May 19, 2022, the FDA updated this safety communication to provide the latest information about medical device reports (MDRs) associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls. In addition, the FDA has taken additional actions since this updated safety communication was i...

SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Inj...
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sterrx-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-5-dextrose-injection-150meq-1000-ml
MedWatch; FDA

May 20th, 2022 - SterRx, LLC today announced the voluntary nationwide recall of three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to waterborne microbial contamination. SterRx, LLC has initiated this voluntary recall of Sodium Bicarbonate injection, to the Hospital Pharmacy level. Intravenous administration of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL, inten...

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sam...
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-issues-nationwide-voluntary-recall-taytullar-softgel-capsules-1mg20mcg-sample-packs-due-out
MedWatch; FDA

May 20th, 2022 - Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were plac...

Triloan ii suik - triamcinolone acetonide injection, suspension-Asclemed USA, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=af3d002d-5e8e-44f6-bdd9-45a99263221b

May 20th, 2022 - Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactio...

Triloan suik - triamcinolone acetonide injection, suspension-Asclemed USA, Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=320f7f0c-177c-42dc-96e6-4d688677c57a

May 20th, 2022 - Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactio...

Pantoprazole sodium - pantoprazole sodium injection, powder, lyophilized, for solution-Gland Pharma Limited
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c1ad8f91-3783-4139-8154-e461a53809c1

May 20th, 2022 - Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: • Short-term Treatment (7 to 10 days) of Gastroesophageal Reflux Disease (GERD) Associated with a History of Erosive Esophagitis (EE). (1.1) •        Pathological Hypersecretion Conditions Including Zollinger-Ellison (ZE) Syndrome. (1.2) Pantoprazole sodium for injection is indicated for short-term treat...

Doxepin hydrochloride - doxepin hydrochloride capsule-Leading Pharma, LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e6a4cb10-1928-4abe-8797-404c9ddc37dd

May 20th, 2022 - Doxepin Hydrochloride is recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). Psychotic d...

Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntar...
https://www.fda.gov/vaccines-blood-biologics/recalls-biologics/urgent-voluntary-recall-corneagen-sclera-scleral-patch-grafts-corneagen-voluntarily-recalling-entire
MedWatch; FDA

May 19th, 2022 - Firm: CorneaGen 1200 6th Ave Suite 300 Seattle, WA 98101 T: 206-701-5840 Lot Number: W419221008338 Product Numbers: W419221008338005; W419221008338006; W419221008338007; W419221008338008; W419221008338009; W419221008338010; W419221008338011; W419221008338012; W419221008338013; W419221008338014; W419221008338015; W419221008338016; W419221008338017; W419221008338018; W419221008338019 On January 5...

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due...
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-one-lot-daptomycin-injection-due-presence-particulate
MedWatch; FDA

May 19th, 2022 - Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any ...

Stay ageless daily moisturizer mineral sunscreen broad spectrum spf 30 - titanium dioxide and zinc oxide liquid-sknvcare, LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de5be09a-196e-753d-e053-2a95a90a616d

May 19th, 2022 - Helps prevent sunburn.Sunscreen

Stay ageless tinted mineral sunscreen broad spectrum spf 30 - titanium dioxide and zinc oxide cream-sknvcare, llc
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de5bcd92-d4bc-5193-e053-2a95a90acfad

May 19th, 2022 - Helps prevent sunburn.Sunscreen

Allergy relief non drowsy - fexofenadine hcl tablet, film coated-Allegiant Health
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=219606a8-9a3e-4c30-adb1-984f3f4e72c7

May 19th, 2022 - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throatAntihistamine

Accrufer - ferric maltol capsule-Shield TX (UK) Ltd
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=367ac157-2d25-4f34-99ce-b126e0f03851

May 19th, 2022 - ACCRUFER is indicated for the treatment of iron deficiency in adults. ACCRUFER is an iron replacement product indicated for the treatment of iron deficiency in adults. ( 1)

Anti-diarrheal - loperamide hydrochloride capsule, liquid filled-HEB
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ea49be2-1744-4d14-bc43-09d35fd4b3c7

May 19th, 2022 - controls symptoms of diarrhea, including Travelers' DiarrheaAnti-diarrheal

Levonorgestrel and ethinyl estradiol - levonorgestrel and ethinyl estradiol tablet-Glenmark Pharmaceuticals Inc., USA
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=44fbc5ae-5682-471f-a12a-955e8b4d233a

May 19th, 2022 - Levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contrac...

Promethazine hydrochloride - promethazine hydrochloride suppository-A-S Medication Solutions
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=46b869e2-9305-43ae-bb15-919a6d09b6ff

May 19th, 2022 - Promethazine HCl Suppositories are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard...

Ceftriaxone sodium - ceftriaxone sodium injection, powder, for solution-REMEDYREPACK INC.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=563bfe04-efb5-43b0-a783-614ea65ccc29

May 19th, 2022 - Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other anti...

Dandruff - pyrithione zinc shampoo-Publix Super Markets, Inc
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c2b8c2-69ea-4343-ae69-43f5966261c2

May 19th, 2022 - helps prevent recurrence of flaking and itching associated with dandruffAnti-dandruff

Meloxicam - meloxicam tablet-REMEDYREPACK INC.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=58556555-ec1f-4977-8c9b-ad77606c3cbb

May 19th, 2022 - Meloxicam is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) (1.1) Rheumatoid Arthritis (RA) (1.2) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3) Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies (14.1)]. Meloxicam is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see C...

Stomach relief regular strength - bismuth subsalicylate liquid-ATLANTIC BIOLOGICALS CORP.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5c02d0ba-91e4-4bd2-ac66-6905323653b2

May 19th, 2022 - relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belchingUpset stomach reliever/Antidiarrheal

Fluconazole - fluconazole tablet-Preferred Pharmaceuticals Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5cbd78cd-2cd7-4882-9902-bdb7812fbc6b

May 19th, 2022 - Fluconazole tablets are indicated for the treatment of: 1.Vaginal candidiasis (vaginal yeast infections due to Candida). 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia...

Calms forte - avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodi...
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=63ce9942-a299-4d9b-b63b-35b297472dc9

May 19th, 2022 - ■ Temporarily relieves symptoms of occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness or irritability

Cetirizine hcl - cetirizine hcl capsule-KROGER COMPANY
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=63ddeea4-d701-42b2-bcb7-81c0e43eb013

May 19th, 2022 - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throatAntihistamine

Daily acne control cleanser - benzoyl peroxide cream-Walgreen Co
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c386b21-0c14-4700-9ef1-837ed4d74a86

May 19th, 2022 - for the treatment of acneAcne medication

Colistimethate sodium - colistimethate sodium injection, powder, lyophilized, for solution-Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a335659-03b0-4a2d-9cd4-7dcf7da96fe6

May 19th, 2022 - Colistimethate for Injection, USP is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Colistimethate for Injection, USP has proven clinically eff...

Cetirizine hcl - cetirizine hcl capsule-AMERISOURCE BERGEN
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=75f2649d-005e-4f16-a7c3-ae966f3a7a00

May 19th, 2022 - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throatAntihistamine

Flovent hfa - fluticasone propionate aerosol, metered-Preferred Pharmaceuticals Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7117b2bb-fcd1-43b8-a78d-3f7f9ceefaa0

May 19th, 2022 - FLOVENT HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use Flovent HFA is not indicated for the relief of acute bronchospasm. FLOVENT HFA is an inhaled corticosteroid indicated for: •Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and olde...

Sulfasalazine - sulfasalazine tablet-REMEDYREPACK INC.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d6cf030-aaed-4427-bceb-b6a04af70bee

May 19th, 2022 - Sulfasalazine tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis.

Terrasil tinea treatment maximum strength - clotrimazole ointment-Aidance Skincare & Topical Solutions, LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=983678a4-5ac7-4903-9e4b-ac28da857758

May 19th, 2022 - Clears up tinea fungal infections including tinea versicolor, tinea corporis, tinea cruris and tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.Antifungal

Clobetasol propionate cream usp, 0.05% clobetasol propionate cream usp, 0.05% - clobetasol propionate usp, 0.05% cream-A-S Medication Solutions
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98b23b99-fab4-49fb-b070-758fb030e9bb

May 19th, 2022 - Clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g /week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (H...

Ibuprofen - ibuprofen capsule, liquid filled-AMERISOURCE BERGEN
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a13cee82-1c4e-0cbe-e053-2a95a90a3ab8

May 19th, 2022 - temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces feverPain reliever/Fever reducer

Ergocalciferol - ergocalciferol capsule, liquid filled-REMEDYREPACK INC.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a80436e0-b507-4e7b-9a60-a9d5ddc4a045

May 19th, 2022 - Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

Spasoap antibacterial - benzalkonium chloride liquid-Right Solutions Corporation, The
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa7e38e0-d601-e0db-e053-2995a90ac47e

May 19th, 2022 - Uses for handwashing or decrease bacteria to the skinPurpose - Antibacterial

Arsenic trioxide - arsenic trioxide injection, solution-Sandoz Inc
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a9008658-c2dd-49f4-b1c4-26e232c81957

May 19th, 2022 - Arsenic trioxide injection is an arsenical indicated: •For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2) Arsenic trioxide injection is indicated for induction of remission and c...

Tamsulosin hydrochloride - tamsulosin hydrochloride capsule-REMEDYREPACK INC.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b30e2bde-b20e-4899-a100-f44170d8165b

May 19th, 2022 - Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperpl...

Gnp regular strength gas relief - dimethicone tablet, chewable-ATLANTIC BIOLOGICALS CORP.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b31257ef-489b-4067-9cc6-8a593d983958

May 19th, 2022 - relieves: pressure bloating symptoms referred to as gasAntigas

No makeup foundation (tan) spf20 - zinc oxide liquid-NV Perricone LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ddc860a7-af8c-faac-e053-2a95a90a555b

May 19th, 2022 - Indications Usage

Duloxetine delayed-release - duloxetine hydrochloride capsule, delayed release pellets-NuCare Pharmaceuticals,Inc.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df61b895-c358-827b-e053-2995a90a9b60

May 19th, 2022 - Duloxetine delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults Chronic musculoskeletal pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (...

Carbamazepine - carbamazepine tablet, extended release-REMEDYREPACK INC.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e38aec1f-19c9-4da3-8cb5-7794ef4cc500

May 19th, 2022 - Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other ty...

Naproxen sodium - naproxen sodium capsule, liquid filled-HEB
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df8ea301-c48b-4da4-9e8e-5c69cac6cba7

May 19th, 2022 - temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces feverPain reliever/fever reducer

Plan b one-step - levonorgestrel tablet-A-S Medication Solutions
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fcc7ba8e-ad54-4efe-87e4-5eb0fbf4f064

May 19th, 2022 - for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)Emergency contraceptive

Antispetic - eucalyptol, menthol, methyl salicylate, thymol mouthwash-Publix Super Markets, Inc
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1046b6b5-b439-4d32-87b3-c118a58bf191

May 19th, 2022 - helps control plaque that leads to gingivitisAntigingivitis, antiplaque

No makeup foundation (buff) spf20 - zinc oxide liquid-NV Perricone LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df5e3b85-a327-37e1-e053-2a95a90a4629

May 19th, 2022 - Indications Usage

Montelukast sodium - montelukast sodium tablet, film coated-REMEDYREPACK INC.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=235baf62-2ce1-4641-b4e0-b30e0269834c

May 19th, 2022 - Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, ...

Carboprost tromethamine - carboprost tromethamine injection, solution-Woodward Pharma Services LLC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1dfd7cfe-2f6d-45e6-bf42-dc44fa8d1fd9

May 19th, 2022 - Carboprost tromethamine, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: Failure of expulsion of the fetus during the course of treatment by another method; Premature rupture of membranes in intrauterine methods with loss...

Tresiba - insulin degludec injection, solution-A-S Medication Solutions
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84197351-cb71-4282-8217-13103404a2b4

May 19th, 2022 - TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use oNot recommended for the treatment of diabetic ketoacidosis. TRESIBA is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus (1). Limitations of Use: •Not recommended for treating diabetic k...

Naproxen sodium - naproxen sodium capsule, liquid filled-MEIJER DISTRIBUTION INC
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f82399-9f71-49dd-8710-b60f346c576c

May 19th, 2022 - temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces feverPain reliever/fever reducer