New Delhi: Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market a generic drug used to treat overactive bladder in adults.
The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fesoterodine Fumarate extended-release tablets in strength of 4 mg and 8 mg, the drug firm said in a statement.
The approved ANDA is therapeutically equivalent to Pfizer Inc's Toviaz extended-release tablets.
Fesoterodine Fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urinary incontinence, urgency and frequency.
According to IQVIA, Fesoterodine Fumarate extended-release tablets (4 mg and 8 mg), have an estimated market size of USD 177 million for twelve months ending September 2022.
Shares of the company were trading 0.34 per cent down at Rs 565.15 apiece on the BSE.