Approval

Alembic Pharma Gets US FDA Nod For Nifedipine ER Tablets

November 23,2022 04:50 AM
- By Admin

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (FDA) 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 i) vasospastic angina ii) chronic stable angina (classical effort-associated angina) and iii) 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 September 2022 according to IQVIA. Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 tentative approvals) from  US FDA.