Alembic Pharmaceuticals Receives USFDA Tentative Approval for lloperidone Tablets

Alembic Pharmaceuticals Limited today announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for lloperidone tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fanapt Tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg, of Vanda Pharmaceuticals, Inc. lloperidone tablets are indicated for the treatment of schizophrenia in· adults. lloperidone Tablets have an estimated market size of USD  128 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 74 ANDA approvals (65 final approvals and 9 tentative approvals) from USFDA. – Medical Buyer Bureau