Alembic Pharma bags USFDA nod for Fesoterodine Fumarate ER Tablets to treat overactive bladder

Vadodara: Alembic Pharmaceuticals Limited today 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 Inc.

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 US$ 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.

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