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04-Jul2017

Alembic Pharma gets USFDA's nod for Vardenafil Hydrochloride Orally Disintegrating Tablets

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vardenafil Hydrochloride Orally Disintegrating Tablets, 10mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) STAXYN Orally Disintegrating Tablets, 10mg, of Bayer Healthcare and is used under license by GlaxoSmithKline.

Vardenafil Hydrochloride Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction. Vardenafil Hydrochloride Orally Disintegrating Tablets have an estimated market size of $9.5 million for twelve months ending December 2016 according to IMS.

Alembic is currently in litigation with Bayer in District Court of Delaware and the launch of this product will depend on the outcome of litigation. The company now has a total of 59 ANDA approvals (52 final approvals and 7 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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