Alembic Pharma receives USFDA’s final approval for Fesoterodine Fumarate extended-release tablets
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Toviaz Extended-Release tablets, 4 mg and 8 mg, of Pfizer
The United States Food and Drug Administration (USFDA) has given final approval to Alembic Pharma’s Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release tablets, 4 mg and 8 mg, a statement from the company said.
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Toviaz Extended-Release tablets, 4 mg and 8 mg, of Pfizer, the statement noted.
It further mentioned that Fesoterodine Fumarate Extended-Release tablets are indicated for the treatment of Over Active Bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency and frequency.
The tablets have an estimated market size of $177 million for 12 months ending September 2022, according to IQVIA, the statement concluded.
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