Alembic Pharmaceuticals (Alembic) 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 ...

seeking authorisation to produce and market a generic version of entacapone (200 mg tablets) in the United States. Entacapone is the active ingredient in Comtan®, a product originated by Orion ...

It is a bioequivalent generic version of Comtan tablets". The company said it will launch the product shortly in the strength of 200mg tablets. This new approval is part of portfolio of products ...