Alembic Pharma gets US FDA nod for nifedipine ER tablets
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,
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