Alembic Pharma gets tentative USFDA approval for depressive disorder drug

Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic Vortioxetine tablets indicated for the treatment of the major depressive disorder.

The tentative approval granted by the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Vortioxetine tablets of strengths in 5 mg, 10 mg, 15 mg and 20 mg, the company said in a statement.

These are 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, it added.

Citing IQVIA data, the company said these Vortioxetine tablets have an estimated market size of USD 1,249 million for twelve months ending September 2021.

Alembic, however, said it is currently in litigation with H Lundbeck in the Court of appeals for the Federal Circuit and the launch of the product will depend on litigation outcome.

"It is possible that our ANDA may not be indicated for certain uses due to unexpired exclusivities for the RLD for such uses," the company said.