Alembic Pharmaceuticals receives US FDA tentative approval for Vortioxetine tablets

Alembic Pharmaceuticals today received tentative approval from the US Food and Drug Administration (FDA) 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 (RLD) product Trintellix tablets 5 mg, 10 mg, 15 mg and 20 mg of Takeda Pharmaceuticals, the company notified via a statement.

Vortioxetine tablets are indicated for the treatment of Major Depressive Disorder (MDD), and have an estimated market size of $1249 million for twelve months ending September 2021 according to IQVIA, it added.

The statement further notified that 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.