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).

Click for more on USFDA

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.

Other drugs approval by USFDA

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
https://thehealthmaster.com/2022/10/18/usfda-gives-tentative-approval-for-valbenazine-capsules/