NEW DELHI, Jan 6: 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.
(PTI)
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