Alembic Pharma receives 11 USFDA product approvals (final & tentative) during quarter ended 30 June
Vadodara: Alembic Pharma has announced the receipt of 11 product approvals both final and tentative from the US Food & Drug Administration (USFDA) during the quarter ended 30th June, 2024.
The Company has received final approvals for Clindamycin Phosphate Topical Gel USP 1% for treatment of acne vulgaris, Diazepam Injection USP, 10mg/2mL (5 mg/mL), Single-Dose Prefilled Syringe for the management of anxiety disorders or for the shortterm relief of the symptoms of anxiety, Tretinoin Cream USP, 0.1% for topical application in the treatment of acne vulgaris, Sacubitril and Valsartan Tablets, 24mg/26mg, 49mg/51mg, and 97mg/103 mg 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
The list further includes Methotrexate Tablets USP, 2.5mg 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 for the treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder, Icatibant Injection, 30mg/3 mL (10 mg/mL) for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older., Dabigatran Etexilate Capsules, 75mg and 150mg 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., Doxycycline Capsules, 40mg for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Additionally, tentative approvals have been received for Selexipag Tablets 1,000mcg and 1,200mcg 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 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, Dabigatran Etexilate Capsules, 110mg 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, Bosutinib Tablets, 100mg and 500mg for the treatment of adult patients with a certain type of leukemia called Philadelphia chromosomepositive chronic myelogenous leukemia.
After these, Alembic has now a cumulative total of 206 ANDA approvals (179 final approvals and 27 tentative approvals) from USFDA.
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