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7th January, 2022, Mumbai: 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) 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 (MDD).
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. Please refer to detailed prescribing information on our label. It is possible that our 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.