Alembic Pharmaceuticals Limited on Friday 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, the pharma major stated.
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 the USFDA.
On Friday, Global pharma major Lupin Limited also announced that it has received approval from the USFDA for its ANDA, Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, to market a generic equivalent of Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc.
The product will be manufactured at Lupin’s facility in Goa, India.