Alembic Pharmaceuticals announces USFDA Tentative Approval for Brexpiprazole Tablets

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical Co., Limited (Otsuka). Brexpiprazole Tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for treatment of schizophrenia. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses. Refer to our label for full indication.

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of US$ 1.6 billion for twelve months ending Dec 2022 according to IQVIA.

Alembic has a cumulative total of 184 ANDA approvals (160 final approvals and 24 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 512.30 as compared to the previous close of Rs. 525.65. The total number of shares traded during the day was 4464 in over 334 trades.

The stock hit an intraday high of Rs. 524.75 and intraday low of 511.00. The net turnover during the day was Rs. 2299589.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA TentativeApproval ANDA BrexpiprazoleTablets