Alembic Pharmaceuticals, a vertically integrated research and development pharma company today received USFDA approval for Darifenacin extended release tablets for the treatment of an overactive bladder.
"We have received approval from the US Food and Drug Administration (USFDA) for our abbreviated new drug application (ANDA) Darifenacin extended-release tablets, 7.5 mg and 15 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Enablex extended release tablets, 7.5 mg and 15 mg of Allergan Pharmaceuticals," a company statement said here.
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