Alembic gets USFDA tentative approval
Mumbai, Feb 2 : Pharma major Alembic Pharma Today said it has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The tentatively 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. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses. Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of $225 million for 12 months ending in September 2021. (UNI)