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

241
USFDA Approval
USFDA Approval

Last Updated on October 2, 2024 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.

USFDA gives nod for Levothyroxine Sodium For Injection

USFDA gives nod for Nifedipine ER tablets

USFDA gives nod for Amphotericin B Liposome Injection

USFDA gives approval for Potassium-deficiency drug

USFDA gives final approval for Cyclophosphamide capsules

USFDA gives nod to market this generic Antibiotic Drug

Gujarat FDCA launches online licensing system for cosmetics

IPC to digitize Indian Pharmacopoeia (IP) soon

DCOIWA’s state-wise training program for drug regulators begins

NPPA fixes Retail Price of one formulation: November 2022

CDSCO gives approval for this Anti-diabetic drug

NPPA releases draft working sheets for ceiling price fixation of 954 formulations

USFDA gives nod for Levothyroxine Sodium For Injection

NPPA fixes Retail Price of 40 formulations: November 2022

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news