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Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, according to IQVIA, the estimated market size for the twelve months ending September 2022 is USD 56 million.
Alembic Pharmaceuticals Limited (Alembic) announced today that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nifedipine Extended Release Tablets USP, 30 mg, 60 mg and 90 mg. the company said in a statement on Monday.
The approved ANDA is for a therapeutically listed drug product (RLD), Procardia XL Extended-Release Tablets, 30 mg, 60 mg, and 90 mg, from Pfizer Inc.
Nifedipine extended-release tablets are indicated for the management of vasospastic angina pectoris, chronic stable angina pectoris (classic effort-associated angina pectoris), and hypertension.
Nifedipine Extended Release Tablets USP, 30 mg, 60 mg and 90 mg, according to IQVIA, the estimated market size for the twelve months ending September 2022 is USD 56 million. Alembic has a total of 177 ANDA approvals (153 final and 24 tentative approvals) from the USFDA.
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