"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 stock was trading 0.24 per cent up at Rs 516.05 on BSE.
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