Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5 mg, 75 mg, and 150 mg. It is bioequivalent to the reference listed drug product (RLD), Effexor XR Extended-Release Capsules of Upjohn US 2 LLC.
Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD) and Panic Disorder (PD)
Granules now have a total of 56 ANDA approvals from US FDA (54 Final approvals and 2 tentative approvals).
The current annual U.S. market for Venlafaxine ER Capsules is approximately $153 Million, according to MAT Mar 2023, IQVIA/IMS Health.