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.