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Alembic Pharma gets USFDA’s nod for Darifenacin Extended Tablets

12 Dec 2017 Evaluate

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its 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. Darifenacin Extended-Release Tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Darifenacin Extended-Release Tablets, 7.5 mg and 15 mg, have an estimated market size of $64 million for twelve months ending December 2016 according to IMS. The company now has a total of 70 ANDA approvals (62 final approvals and 8 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.

Alembic Pharma Share Price

765.70 2.15 (0.28%)
22-Apr-2026 11:05 View Price Chart
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