US FDA gives final approval to Alembic Pharma’s Nifedipine extended-release tablets

The US Food and Drug Administration (FDA) today gave the final approval to Alembic Pharma 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 (RLD) product, Procardia XL extended-release tablets, 30 mg, 60 mg and 90 mg, of Pfizer Inc. The tablets are indicated for the management of vasospastic angina, chronic stable angina (classical effort-associated angina) and hypertension, a statement from Alembic Pharma said.

The tablets have an estimated market size of $56 million for 12 months ending September 2022 according to IQVIA, the statement added.