Alembic’s anti-depression generic receives tentative FDA approval

GUJARAT, India — Alembic Pharmaceuticals has received tentative approval from the Food and Drug Administration for its anti-depressive medication vilazodone hydrochloride, according to several published reports.

Tentative approval is given when a generic drug is ready for approval before the patent exclusivity for the reference product has ended. Final approval is delayed until that time.

"The company has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for vilazodone hydrochloride tablets, 10mg, 20mg and 40mg," the company stated in a filing.

The FDA-approved product is therapeutic equivalent to the reference-listed drug product Viibryd tablets of Forest Labs. 

According to IMS, the U.S. market for these tablets was $340 million in 2016.

Alembic currently has a total of 54 abbreviated New Drug Application approvals from the FDA, 47 of which are final and seven are tentative.