Mumbai: Alembic Pharmaceuticals Limited announced that it 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.

This ANDA is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urinary incontinence, urgency, and frequency.

Fesoterodine Fumarate Extended-Release tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022 according to IQVIA.

Alembic had previously received tentative approval for this ANDA.
https://thehealthmaster.com/2023/01/06/usfda-approves-fesoterodine-fumarate-extended-release-tablets/