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ALLMedicine™ Detailed topics Center - Drugs

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.

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

May 27th, 2020 - The efficacy and safety of GOCOVRI® 274 mg were evaluated in two Phase 3, randomized, placebo-controlled trials

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

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.

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.

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 ...

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.

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.

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 23rd, 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).

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.

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.

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

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

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.

Semglee® | Insulin glargine injection | HCP Website
https://www.semglee.co.uk/en-gb

Semglee® is an approved biosimilar of reference insulin glargine. It is indicated for treatment of diabetes mellitus in adults, adolescents & children over 2 years of age.

Now Approved | MenQuadfi (Meningococcal [Groups A, C, Y, W and Y)
https://www.menquadfi.com/

MenQuadfi is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidisserogroups A, C, W, and Y. MenQuadfi is approved for use in individuals 2 years of age and older. MenQuadfi does not prevent N. meningitidisserogroup B disease.

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-ramucirumab-plus-erlotinib-first-line-metastatic-nsclc
FDA

On May 29, 2020, the Food and Drug Administration approved ramucirumab (CYRAMZA, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer
FDA

Jun 14th, 2020 - On June 15, 2020, the Food and Drug Administration granted accelerated approval to lurbinectedin(ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

FDA approves nivolumab for esophageal squamous cell carcinoma
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-esophageal-squamous-cell-carcinoma
FDA

Jun 9th, 2020 - On June 10, 2020, the Food and Drug Administration approved nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

ZEPZELCA™ (lurbinectedin) - Now Approved Treatment‎
https://www.zepzelca.com/

Learn About Now Approved ZEPZELCA On The Official Patient Website Today. Patient Information. Prescribing Info. Safety Profile Info. Resources & Support. Now FDA Approved. Treatment Information. Important Safety Info.

Pemazyre™ (pemigatinib) - Official Pemazyre HCP Website‎
https://hcp.pemazyre.com

Visit A Site For Healthcare Professionals To Learn Important Information On Pemazyre. Discover A Treatment Option For Your Patient And Read About The Usage And Indications. Recommended Dosing. Safety Profile. Clinical Response Rates. Prescribing Information.

Emerphed | The first and only FDA approved ready-to-use ephedrine
https://www.emerphed.com

Overdose of EMERPHED can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician.

TUKYSA™ (tucatinib) tablets - Information for Physicians‎
https://www.tukysahcp.com

Request a Rep Visit, or Register to Get Updates & Stay Informed About TUKYSA™ Today. Prescribing Information. Now Approved. Learn More. Official Physician Site.

Now Approved: TRODELVY™ - Sacituzumab Govitecan-hziy‎
https://www.trodelvy.com

Official Site: Learn about TRODELVY™, Clinical Study Results. FDA approved. See Full Safety and Prescribing Information including boxed Warning. Prescribing Information. Safety. Dosing. Financial Support.

KOSELUGO™ (selumetinib) - Official Website‎
https://www.koselugo.com

Learn More Information About Now FDA-Approved KOSELUGO On The Official Site. Resources Available. Important Safety Info. Indication Info. Download Prescribing Info. Access 360 Program. Insurance coverage: Financial Support Info, Access 360 Program.

FDA approves niraparib for first-line maintenance of advanced ovarian cancer
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-niraparib-first-line-maintenance-advanced-ovarian-cancer
FDA

Apr 28th, 2020 - The Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-capmatinib-metastatic-non-small-cell-lung-cancer
FDA

May 5th, 2020 - On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

Retevmo™ (selpercatinib)‎ - Visit The Official Site‎
https://www.retevmo.com/

View Safety & Prescribing Information On The Official Patient Site. Learn How Retevmo™ Works And How It May Help Eligible Patients. Savings & Support. Dosing and Administration. About RETEVMO™. Types: Patient Resources, Treatment Information, Safety Information.

DARZALEX Faspro™ - Info for Physicians‎
https://www.darzalexhcp.com

(daratumumab and hyaluronidase human-fihj) Learn More at the Official Physician Site. Prescription Assistance. Patient Support Program. Dosing Admin & Safety. Janssen CarePath. Official Physician Site. Learn About Multiple MOAs. Patient Dosing Schedule.

TABRECTA™ (capmatinib) - Now Approved - HCP Site‎
https://www.hcp.novartis.com/products/tabrecta/met-exon-14-skipping-mutation-nsclc/efficacy/?site=MTX-1228793GK104516&source=01030&gclid=EAIaIQobChMIqfz855_K6QIVCZezCh1p0gOqEAAYAiAAEgJWYPD_BwE&gclsrc=aw.ds

HCPs, Visit The Official Site For Information About TABRECTA™ As A Treatment Option. See If TABRECTA™ Could Be Right For Your Patients. Full Safety Profile. Patient Co-Pay Program. Mechanism Of Action. Newly FDA Approved. Official HCP Website. Clinical Trial Data.

ZEJULA® (niraparib) HCP Site - Oral Treatment Option‎
https://www.zejula.com/en/hcp

Visit our website to find information on efficacy, safety, and dosing. HCP Resources. Treatment Sequencing. Patient Stories. Prescribing Information. Dose Modification. Zejula ovarian cancer niraparib Zejula

HUMIRA (adalimumab) INJECTION
https://www.humirapro.com/

Official health care professional site from AbbVie Inc. Find safety and prescribing information, including BOXED WARNING, for HUMIRA (adalimumab).

A First-line Oral Treatment for Certain People with Gaucher Disease Type 1
http://www.cerdelga.com/healthcare-professionals.html

CERDELGA is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.

ADEMPAS (riociguat) tablets
http://adempas-us.com/hcp/

Adempas (riociguat). Visit Adempas-US.com to see full safety and prescribing information, including Boxed Warning. Learn about Adempas and the Aim Patient Support Program.

ACNIZIL™ topical gel
https://www.henryschein.com/us-en/Medical/ShopExp/Acnizil.aspx

Acnizil™ is a new first-line therapy product for mild to severe acne. It is made from a proprietary silver solution

Abbott RealTime IDH1
https://www.molecular.abbott/us/en/products/oncology/realtime-idh1

An in vitro polymerase chain reaction (PCR) assay for the qualitative detection of single nucleotide variants (SNVs)

ACTEMRA® (tocilizumab) intravenous drip infusion or injection
https://www.actemrahcp.com/

Find valuable ACTEMRA® (tocilizumab) information, including an ACTEMRA® dosing calculator, RA patient brochure, ACTEMRA® prescription guide and the ISI. IMPORTANT SAFETY INFORMATION-RA: ACTEMRA is a prescription medicine called an interleukin-6 (IL-6) receptor antagonist.

AcrySof IQ Cataract IOLs | myalcon.com
https://www.myalcon.com/products/surgical/acrysof-iq-cataract-iols/index.shtml

Explore AcrySof IQ intraocular lenses for your cataract surgery and the AcrySof® Advantage at myalcon.com.

ADLYXIN (lixisenatide)
https://www.adlyxinpro.com/

Learn about Adlyxin™ (lixisenatide) injection, a GLP-1 receptor agonist to help improve glycemic control in adults with type 2 diabetes indicated as an adjunct to diet and exercise.

ABILIFY MAINTENA® (aripiprazole) injection
https://abilifymaintenahcp.com/

ABILIFY MAINTENA for the treatment of schizophrenia and the maintenance treatment of bipolar I disorder in adult patients. See full Safety and Prescribing Information, including BOXED WARNING.

Adcirca® (tadalafil)
http://www.adcirca.com/hcp/index.aspx

ADCIRCA is a trademark of Eli Lilly and Company. http://pi.lilly.com/us/adcirca-ppi.pdf. Please see Important Safety Information and Full Prescribing Information.

ADPKD Treatment | JYNARQUE™ HCP (tolvaptan) tablets
https://www.jynarquehcp.com/

The first and only FDA-approved treatment indicated to slow kidney function decline and kidney cyst growth in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

ACTICLATE® (doxycycline hyclate USP) tablets
http://aquapharm.com/acticlate.php

ACTICLATE® (doxycycline hyclate USP) Tablets are indicated for adjunctive therapy in severe acne. Click here for Full Prescribing Information for ACTICLATE® Tablets. Important Safety Information Regarding ACTICLATE® (doxycycline hyclate USP) Tablets, 150 mg and 75 mg.

ABIOMED | Impella RP
http://www.abiomed.com/impella/impella-rp

The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area

ADDERALL XR®
http://www.shirecontent.com/PI/PDFS/AdderallXR_USA_ENG.PDF

ADDERALL XR, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

ADYNOVATE®
http://adynovatepro.com

The official ADYNOVATE site for healthcare professionals.

ACTIQ® (fentanyl citrate
http://www.actiq.com/

INDICATIONS AND USAGE. ACTIQ® oral transmucosal lozenge, CII is indicated for the management of breakthrough pain in cancer patients 16 years of age

ADDYI (flibanserin) tablets
http://addyi.com/hcp

Discover how ADDYI increased sexual desire and decreased associated distress in premenopausal women with acquired, generalized HSDD. See full safety info.

ACZONE® GEL (dapsone)
http://aczonehcp.com

Find ACZONE® Gel dosage, side effects, efficacy, patient savings program, and pivotal trial information all in one place. View important safety information.