Alembic Pharmaceuticals Tuesday said it has received approval from the US health regulator to market Vardenafil Hydrochloride orally disintegrating tablets, used to treat erectile dysfunction.
The company has received nod from the US Food & Drug Administration (USFDA) to market the drugm, which is therapeutically equivalent to Bayer Healthcare Pharmaceuticals's Staxyn, Alembic said in a regulatory filing.
The company had previously received tentative approval for this product from the USFDA.
According to IQVIA, Hydrochloride orally disintegrating tablets have an estimated market size of USD 8 million for twelve months ending December 2017.
Alembic said it has now has a total of 78 abbreviated new drug application (ANDA) approvals from the US health regulator.
Shares of Alembic Pharmaceuticals Tuesday ended 0.86 per cent up at Rs 567.45 on the BSE.
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