Alembic Pharma receives tentative approval for vortioxetine tablets

Alembic Pharmaceuticals on Friday announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for vortioxetine tablets.

Vortioxetine tablets are indicated for the treatment of major depressive disorder. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) trintellix tablets Takeda Pharmaceuticals, USA, lnc.

According to IQVIA, vortioxetine tablets have an estimated market size of $1249 million for twelve months ending September 2021.

Alembic said it 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.

Alembic Pharma 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.

Shares of Alembic Pharma were trading 0.46% lower at Rs 816.70.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

On a consolidated basis, the drug maker's net profit dropped 49.22% to Rs 169.29 crore on 11.31% decline in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.

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