Alembic Pharmaceuticals receives USFDA approval for Nifedipine Extended-Release Tablets

26 Nov 2022 , 01:34 AM

Alembic Pharmaceuticals 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 90mg 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 Sep 2022 according to IQVIA