Mumbai, Jan 7 : Pharma Alembic Pharmac Today  said it has received tentative approval from the US Food and 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.(UNI)