Granules India gets Venlafaxine ER Capsules FDA approval

Granules India has secured approval for its abbreviated new drug application (ANDA) for Venlafaxine Hydrochloride Extended-Release (ER) Capsules USP, 37.5 mg, 75 mg, and 150 mg from the US Food and Drug Administration (FDA).

Venlafaxine ER Capsules is bioequivalent to Upjohn US 2’s Effexor XR Extended-Release Capsules, said the Indian pharma company.

Venlafaxine HCl extended-release capsules are approved for the treatment of major depressive disorder (MDD), social anxiety disorder (SAD), panic disorder (PD), and generalized anxiety disorder (GAD).

As per MAT Mar 2023, IQVIA/IMS Health, Venlafaxine ER Capsules has a current annual market of around $153 million in the US.

Granules India has 56 ANDA approvals from the FDA, now of which 54 are final approvals and the remaining are tentative approvals.