Last Updated on October 10, 2024 by The Health Master
Ahmedabad: Zydus Lifesciences Limited’s subsidiary Zydus Worldwide DMCC has received tentative approval from the United States Food and Drug Administration (USFDA) to market Valbenazine capsules USP 40 mg, 60 mg, and 80 mg.
Valbenazine capsules are indicated for the treatment of adults with tardive dyskinesia (movements in the face, tongue, or other body parts that cannot be controlled).
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
According to IQVIA MAT Aug 2022 data, Valbenazine capsules had annual sales of USD 781 million in the United States.
USFDA gives nod for Extended Phenytoin Sodium Capsules
USFDA gives final approval for Brivaracetam tablets
USFDA tentative approves Amantadine extended-release capsules
USFDA gives nod for this generic drug for urinary issues
USFDA gives approval for Sildenafil for oral suspension
USFDA approved this drug to prevent nerve cells dying prematurely
CDSCO Panel gives nod to study Anti Allergic Combination Drug
DCGI notifies classification of 48 Medical Devices related to Oncology under MDR 2017
CDSCO Panel gives nod to study Elagolix Tablet
Procedure to obtain registration for Blood Storage Centre
DTAB seeks report on FDCs related to vitamins, minerals formulations from Kokate Committee
USFDA gives nod for Extended Phenytoin Sodium Capsules
DCGI notifies classification of 95 Medical Devices related to dental healthcare under MDR, 2017
NIPER gets patent for its invention for new anti-TB compound
CDSCO Panel gives nod to Manufacture, Market Progesterone SR Tablet
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: