Alembic Pharma Gets U.S. FDA Nod For Generic Medication
Fesoterodine Fumarate extended-release tablets are indicated for the treatment of overactive bladder in adults.
Alembic Pharmaceuticals on Friday said it has received approval from the U.S. health regulator to market a generic drug used to treat overactive bladder in adults.
The company has received final approval from the U.S. Food & Drug Administration 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 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 $177 million for twelve months ending September 2022.
Shares of the company were trading 0.34% down at Rs 565.15 apiece on the BSE.