Alembic Pharmaceuticals gets FDA approval for Toviaz generic

Alembic Pharmaceuticals said that it has secured tentative approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for its generic drug product Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg.

The tentatively approved product is the generic of Pfizer‘s Toviaz Extended-Release Tablets, 4 mg and 8 mg.

Fesoterodine Fumarate Extended Release Tablets are approved for the treatment of overactive bladder (OAB) in adults having the symptoms of urge urinary incontinence, urgency, and frequency. The drug product may not be indicated for some other uses because of unexpired exclusivities for the reference listed drug for such uses.

According to IQVIA, the estimated market size of Fesoterodine Furnarate Extended-Release Tablets, 4 mg and 8 mg is $225 million for 12 months ending September 2021.

Alembic Pharmaceuticals said that it has secured 20 approvals this year so far, which include 14 final approvals and half a dozen tentative approvals, and a total of 159 ANDA approvals from the FDA.