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12-Dec2017

Alembic Pharma gets USFDA's nod for Darifenacin Extended Tablets

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.


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