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Alembic Pharmaceuticals gets USFDA’s final nod for Fesoterodine Fumarate Extended-Release Tablets

06 Jan 2023 Evaluate

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.

Alembic Pharma Share Price

785.40 8.05 (1.04%)
08-May-2026 16:59 View Price Chart
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