Granules India bags USFDA nod for Venlafaxine Hydrochloride ER Capsules
Venlafaxine HCl extended-release capsules are indicated for the treatment of Major Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder and Panic Disorder.;
Hyderabad: Drugmaker, 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.
Read also: USFDA nod to Granules India postherpetic neuralgia drug Gabapentin
Medical Dialogues team had earlier reported that the USFDA had approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI) for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg.
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