Alembic Pharmaceuticals receives USFDA Tentative Approval for Vortioxetine Tablets

Alembic Pharmaceuticals Limited (Alembic) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trintellix Tablets 5 mg, 10 mg, 15 mg, and 20 mg, of Takeda Pharmaceuticals, USA, Inc. (Takeda). Vortioxetine Tablets are indicated for the treatment of major depressive disorder (MOD).

Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg have an estimated market size of US$ 1249 million for twelve months ending September 2021 according to IQVIA. Alembic is currently in litigation with H.Lundbeck in Court of Appeals 'for the Federal Circuit and launch of the product will depend on litigation outcome. Refer to detailed prescribing information on the label. It is possible that the ANDA may not be indicated for certain uses due to unexpired exclusivities for the RLD for such uses.

Alembic has received year to date (YTD) 18 approvals (13 final approvals and 5 tentative approvals) and a cumulative total of 157 ANDA approvals (136 final approvals and 21 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 820.50 as compared to the previous close of Rs. 816.20. The total number of shares traded during the day was 46600 in over 1868 trades.

The stock hit an intraday high of Rs. 826.90 and intraday low of 800.00. The net turnover during the day was Rs. 38229715.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 TentativeApproval USFDA ANDA VortioxetineTablets