Granules India received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride Extended-Release Capsules.
The approved drug 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 USFDA (54 final approvals and two tentative approvals).
The current annual U.S. market for Venlafaxine ER Capsules is approximately $153 million, according to IQVIA/IMS Health, the company said in a release.