JB Pharma announces USFDA approval for its generic Venlafaxine Extended Release Tablets

JB Pharma, one of the fastest growing pharmaceutical companies in India, today, has announced that it has received final approval from 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, an advanced and precision controlled release mechanism – an area where JB has seen success with 3 products already in the US market. JB Pharma now has 17 US 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 U.S. 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 Oct 2022 data, Venlafaxine Extended-Release tablets recorded annualized sales of approximately $ 48 million in the US.

Commenting on the approval, Mr. Nikhil Chopra, CEO and Wholetime Director, JB Pharma said, “Venlafaxine extended release tablets will be our fourth offering in the US market based on advanced OROS (Osmotic controlled Release Oral delivery System) technology, which demonstrates JB Pharma’s ability to leverage and deliver quality products using its OROS platform and deliver high quality medicines to patients. We remain committed to expand our brand portfolio in structured and strategic way”.