USFDA gives final nod to Alembic Pharmaceuticals’ tablets for overactive bladder

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.
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