JB Pharma bags USFDA nod for Major Depressive Disorder drug Venlafaxine Extended Release
A selective serotonin and norepinephrine reuptake inhibitor (SNRI), Venlafaxine Extended-Release tablets are indicated for Major Depressive Disorder (MDD) and Social Anxiety Disorder (SAD).
New Delhi: JB Pharma today announced that the company has received final approval from US Food and Drug 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, an advanced and precision-controlled release mechanism...
New Delhi: JB Pharma today announced that the company has received final approval from US Food and Drug 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, 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 & 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 increasing our offerings in the US market using a structured and strategic approach".
Read also: JB Pharma records revenue growth of 36 percent to Rs 809 crores in Q2 FY23
Established in 1976, JB Pharma, is one of the fastest-growing pharmaceutical companies in India. In India, the company has five brands among the top 300 IPM brands in the country. The company exports its finished formulations to over 40 countries including the USA. It has seven states of the art manufacturing facilities in India including a dedicated manufacturing facility for lozenges. The manufacturing facilities are certified by leading regulators across the world.
Read also: JB Pharma strengthens its position in Gastroenterology with launch of RANRAFT
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