Alembic Pharmaceuticals Limited 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 US$ 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.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.517.35 as compared to the previous close of Rs. 514.6. The total number of shares traded during the day was 3487 in over 182 trades.
The stock hit an intraday high of Rs. 524.95 and intraday low of 513.9. The net turnover during the day was Rs. 1804468.