Dec 15th, 2019 - Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascula...

Dec 11th, 2019 - GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP). GIVLAARI is an aminolevulinate synthase 1-directed small interfering RNA indicated for the treatment of adults with acute hepatic porphyria (AHP). (1)

Dec 10th, 2019 - KOĀTE® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency). Limitation of Use KOĀTE is not indicated for the treatment of von Willebrand disease. KOĀTE is a human plasma-derived antihemophilic factor indicated for the c...

Dec 9th, 2019 - RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation (1.1). Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of...

Dec 9th, 2019 - Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Dec 9th, 2019 - When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic d...

Dec 9th, 2019 - NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. (1)

Dec 9th, 2019 - Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Dec 8th, 2019 - Imatinib mesylate tablets are 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 inte...

Dec 7th, 2019 - When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatme...

Dec 5th, 2019 - Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures), and portacav...

Dec 5th, 2019 - Decitabine for injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in trans...

Dec 5th, 2019 - Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Vitamin K1 Injection is indicated in: anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; prophylaxis an...

Dec 4th, 2019 - Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and, pulmonary embolism; Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; Atrial fibrillation with embolization; Treatment of acute and chronic consum...

Dec 4th, 2019 - MYLOTARG is a CD33-directed antibody-drug conjugate indicated for: treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults (1.1). treatment of relapsed or refractory CD33-positive AMLin adults and in pediatric patients 2 years and older (1.2). MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults. MYLOTARG is indicate...

Dec 4th, 2019 - Ranitidine tablets, USP is indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies h...

Dec 3rd, 2019 - Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%. Desmopressin acetate will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure. Desmopressin acetate will also stop bleeding in hem...

Dec 2nd, 2019 - CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). (1)

Dec 2nd, 2019 - Zometa is a bisphosphonate indicated for the treatment of: Hypercalcemia of Malignancy (1.1) Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) Limitations of Use: The safety and efficacy of Zometa has n...

Dec 2nd, 2019 - RITUXAN HYCELA is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult patients with: Follicular Lymphoma (FL) (1.1) Relapsed or refractory, follicular lymphoma as a single agent Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or...