New Delhi: Alembic Pharmaceuticals has received tentative approval from the US health regulator for vardenafil hydrochloride tablets used for treatment of erectile dysfunction.
“The company has received tentative approval from the United States Food and Drug Administration (USFDA) for its ANDA for vardenafil hydrochloride orally disintegrating tablets,” Alembic Pharmaceuticals said in a BSE filing.
The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to Bayer Healthcare’s Staxyn orally disintegrating tablets.
“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,” it added.
According to IMS December 2016 data, vardenafil hydrochloride tablets had an estimated market size of USD 9.5 million.
The company now has a total of 59 ANDA approvals from the USFDA.