Alembic Pharmaceuticals receives USFDA Tentative Approval for Fesoterodine Fumarate Extended-Release Tablets
Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & 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).











