Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The 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). Fesoterodine Fumarate Extended-Release Tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of $177 million for twelve months ending Sep 2022 according to IQVIA. Alembic had previously received tentative approval for this ANDA. Alembic has a cumulative total of 179 ANDA approvals (157 final approvals and 22 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
