Alembic receives tentative approval for anti-depressive generic

19 April 2017

Indian generic drugmaker Alembic Pharmaceuticals (BSE: 533573) has received tentative approval from the US Food and Drug Administration for anti-depressive medication vilazodone hydrochloride.

Tentative Approval, which does not allow the applicant to market the product, 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 is in litigation with New York-based Forest Laboratories regarding the reference drug Viibryd. Forest Labs is now part of Allergan (NYSE: AGN).

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