Alembic Pharma Gets USFDA Nod for Darifenacin ER Tab | CORPORATE ETHOS

Alembic Pharma Gets USFDA Nod for Darifenacin ER Tab

By: | December 12, 2017
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Dec 12: Drug maker Alembic Pharmaceuticals Ltd on Tuesday said that the company has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Darifenacin Extended-Release Tablets, 7.5 mg and 15 mg.

According to the company, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Enablex Extended-Release Tablets, 7.5 mg and 15 mg, of Allergen Pharmaceuticals.

“Darifenacin Extended-Release Tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency,” the company said.

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.

Alembic now has a total of 70 ANDA Approvals (62 final approvals and 8 tentative approvals) from the USFDA.