Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Iloperidone 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. Iloperidone tablets are indicated for the treatment of schizophrenia in adults.
Iloperidone Tablets have an estimated market size of $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.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
