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) Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg.
According to the company’s press statement, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Procardia XL Extended-Release Tablets, 30 mg, 60 mg and 90 mg, of Pfizer Inc. Nifedipine Extended-Release Tablets.
The drug is indicated for the management of Vasospastic Angina, Chronic Stable Angina (Classical Effort-Associated Angina), and hypertension.
Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg, have an estimated market size of US$ 56 million for twelve months ending Sep 2022 according to IQVIA.
Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 tentative approvals) from the USFDA.