US FDA approves JB Pharma’s generic Venlafaxine extended-release tablets

The US Food and Drug Administration (FDA) has approved JB Pharma’s Abbreviated New Drug Application (ANDA), Venlafaxine extended-release tablets 37.5 mg, 75 mg, 150 mg and 225 mg, a statement from JB Pharma notified.

The 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 three products already in the US market.

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 Pharma. A selective Serotonin and Norepinephrine Reuptake Inhibitor (SNRI), Venlafaxine Extended-Release tablets are indicated for Major Depressive Disorder (MDD) and Social Anxiety Disorder (SAD).

Nikhil Chopra, CEO and Wholetime Director, JB Pharma, said in the statement, “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…….. strategic way.”