Alembic Pharmaceuticals receives USFDA approval (final & tentative) for 11 products

Alembic Pharmaceuticals has received 11 US Food & Drug Administration (USFDA) Product Approvals (Final & Tentative) during the quarter ended 30 June 2024. The products and indication is summarized as under:

Clindamycin Phosphate Topical Gel USP 1% Clindamycin phosphate gel is indicated in the treatment of acne vulgaris.Diazepam Injection USP, 10mg/2mL (5 mg/mL), Single-Dose Prefilled Syringe Diazepam Injection USP Diazepam is indicated for the management of anxiety disorders or for the shortterm relief of the symptoms of anxiety. Selexipag Tablets 1,000mcg and 1,200mcg. Selexipag tablets are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.Binimetinib Tablets 15mg Binimetinib tablet is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.Tretinoin Cream USP, 0.1%, Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris.Sacubitril and Valsartan Tablets, 24mg/26mg, 49mg/51mg, and 97mg/103 mg. Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. It is also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older.Methotrexate Tablets USP, 2.5mg Methotrexate Tablets are indicated for the treatment of neoplastic diseases, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriasis.Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5mg, 75mg, and 150mg. Venlafaxine Hydrochloride Extended-Release Capsules are indicated for the treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder.Icatibant Injection, 30mg/3 mL (10 mg/mL) Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.Dabigatran Etexilate Capsules, 75mg and 150mg 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.Dabigatran Etexilate Capsules, 110mg 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 patientsDoxycycline Capsules, 40mg. Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.Bosutinib Tablets, 100mg and 500mg Bosutinib tablets are indicated for the treatment of adult patients with a certain type of leukemia called Philadelphia chromosomepositive chronic myelogenous leukemia.

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