JB Pharma, one of the fastest growing pharmaceutical companies in India, on Wednesday, 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.
According to the company’s statement, this product is based on Osmotic Controlled Release Oral Delivery System (OROS) 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),” the company said in a statement.
As per IQVIA Health MAT Oct 2022 data, Venlafaxine Extended-Release tablets recorded annualized sales of approximately $ 48 million in the US.
“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 expanding our brand portfolio in structured and strategic way,” Nikhil Chopra, CEO and Wholetime Director, JB Pharma said in a statement.