US FDA approves Granules India’s Abbreviated New Drug Application

Granules announced that US Food & Drug Administration (US FDA) has approved its ANDA for Venlafaxine Hydrochloride Extended-Release Capsules.

Hyderabad: Granules India Limited announced 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.

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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, a press release said.