Last Updated on October 17, 2024 by The Health Master
Alembic Pharmaceuticals Limited has received final approval from the US Food and 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:
- i) vasospastic angina
- ii) chronic stable angina (classical effort-associated angina)
- iii) hypertension.
According to IQVIA, the market for nifedipine extended-release tablets (USP), 30 mg, 60 mg, and 90 mg, is worth US$ 56 million in the year ending September 2022.
Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 tentative approvals) from the USFDA.
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