NE HEALTH BUREAU
MUMBAI, AUG 19
Alembic Pharmaceuticals Limited on Tuesday announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Macitentan Tablets, 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc. (Actelion).
Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. Refer label for a detailed indication.
Macitentan Tablets, 10 mg, have an estimated market size of US$ 1,180 million for twelve months ending June 2025 according to IQVIA.
Alembic Pharma receives USFDA final approval for Tretinoin Cream
Alembic Pharmaceuticals Limited on Monday announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.025%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Refer label for a detailed indication.
Tretinoin cream USP, 0.025%, has an estimated market size of US$ 94 million for twelve months ending June 2025 according to IQVIA.
Alembic has a cumulative total of 224 ANDA approvals (203 final approvals and 21 tentative approvals) from USFDA.
