Alembic Pharmaceuticals gets final USFDA approval for Nifedipine

Alembic Pharmaceuticals Limited 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.

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 are indicated for the management of vasospastic angina, chronic stable 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.