Alembic Pharmaceuticals has said that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg.
Fesoterodine Fumarate extended-release Tablets are used for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency, reported Business Standard. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. (Pfizer).
According to IQVIA data, Fesoterodine Furnarate Extended-Release Tablets, 4 mg and 8 mg have an estimated market size of US$ 225 million for twelve months ending September 2021.