Alembic Pharmaceuticals (Alembic) announced that it has received final FDA approval for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pfizer Inc.’s Toviaz Extended-Release Tablets, 4 mg and 8 mg.
Fesoterodine Fumarate Extended-Release Tablets are used to treat overactive bladder (OAB) symptoms such as urge urinary incontinence, urgency, and frequency in adults. According to IQVIA, the market for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, is worth US$ 177 million in the twelve months ending September 2022. This ANDA had previously received preliminary approval from Alembic. Alembic has received 179 ANDA approvals from the USFDA (157 final approvals and 22 tentative approvals).