Alembic Pharma Gets USFDA Nod for Vardenafil Hydrochloride Orally Disintegrating Tab – CORPORATE ETHOS

Alembic Pharma Gets USFDA Nod for Vardenafil Hydrochloride Orally Disintegrating Tab

By: | November 20, 2018

Nov 20: Drug maker Alembic Pharmaceuticals Ltd on Tuesday announced that the company has received approval from the US Food & Drug·Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg (base).

According to the company, the approved
ANDA is therapeutically equivalent to the reference listed drug product (RLD), Staxyn Orally Disintegrating Tablets, 10 mg, of Bayer Healthcare Pharmaceuticals, Inc. Vardenafil Hydrochloride Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction. Alembic had previously received tentative approval for this ANDA.

Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg, have an estimated market size of $ 8 million for twelve months ending December 2017 according to IQVIA.

Alembic now has a total of 78 ANDA approvals (65 final approvals and 13 tentative approvals) from USFDA.