Alembic Pharma gets USFDA nod for Entacapone Tablet


Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Entacapone Tablets USP, 200 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets, 200 mg, of Orion Corporation. Entacapone Tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease.

Alembic Pharmaceuticals was quoting at Rs 819.05, up Rs 2.85, or 0.35 percent.

News Source:- Moneycontrol

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