USFDA gives approval for Venlafaxine ER tablets

This product is based on OROS (osmotic controlled release oral delivery system) technology, which is an advanced and precise controlled release mechanism

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USFDA Approval

Last Updated on December 2, 2022 by The Health Master

Indian pharmaceutical company JB Pharma has announced that it has received final approval from the US Food and Drugs Administration (USFDA) for its Abbreviated New Drug Application (ANDA), venlafaxine extended-release tablets (37.5 mg, 75 mg, 150 mg, and 225 mg).

This product is based on OROS (osmotic controlled release oral delivery system) technology, which is an advanced and precise controlled release mechanism—an area in which JB Pharma has already seen success with three products in the US market.

JB Pharma now has 17 USFDA ANDA approvals.

The generic product approval is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), venlafaxine hydrochloride extended-release tablets, 37.5 mg, 75 mg, 150 mg, and 225 mg, of Osmotica Pharmaceutical US LLC.

A selective serotonin and norepinephrine reuptake inhibitor (SNRI), venlafaxine extended-release tablets are indicated for major depressive disorder (MDD) and social anxiety disorder (SAD).

As per IQVIA Health MAT October 2022 data, venlafaxine extended-release tablets recorded annualized sales of approximately $48 million in the US.

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