Alembic Pharmaceuticals Limited (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Selexipag for Injection, 1,800 mcg/vial.
Alembic`s Generic Bromfenac Sodium Receives Approval in US
The company said Ivosidenib tablets are indicated for patients with newly diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
Alembic`s Generic Doxycycline Receives Approval in US
Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg and 150 mg and Tentative approval for Dabigatran Etexilate Capsules, 110 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer). Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients; treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients. Refer label for a detailed indication.
Alembic has received the Food and Drug Administration's blessing for Icatibant Injection, 30 mg/3 ml (10 mg/ml) Single-Dose Prefilled Syringe, which is the generic of Takeda's Firazyr. The medication is used for the treatment of acute attacks of hereditary angioedema in adults 18 years of age and older
Alembic Generic Dabigatran Etexilate Mesylate Receives Tentative Approval in US
Alembic Generic Dabigatran Etexilate Mesylate Receives Approval in US
Alembic Generic Icatibant Acetate Receives Approval in US
Alembic`s Generic Clindamycin Phosphate Receives Approval the U.S.