Alembic Pharmaceuticals 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, lnc.. (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 $ 1249 million for twelve months ending September 2021 according to IQVIA. 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.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
