Alembic Pharma receives US FDA tentative approval for Fesoterodine Fumarate extended-release tablets

Alembic Pharmaceuticals today received tentative approval from the US Food and Drug Administration (FDA) 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 (RLD) product Toviaz extended-release tablets, 4 mg and 8 mg, of Pfizer Inc, Alembic Pharma informed in a statement.

It also said that 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 twelve months ending September 2021, according to IQVIA, the statement added.