USFDA gives nod to Zydus to market Dapagliflozin tablets

The medicine works by increasing the removal of sugar by kidneys.

346
USFDA Approval
USFDA Approval

Last Updated on October 10, 2024 by The Health Master

Zydus Cadila announced that it has received final approval from the US Food and Drug Administration (USFDA) to market type 2 diabetes drug dapagliflozin in the country.

The approval is for dapagliflozin tablets in the strengths of 5 mg and 10 mg. The drug is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes.

It also lowers the risk of heart failure in adults with type 2 diabetes with heart disease. It is also used to lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease.

The medicine works by increasing the removal of sugar by kidneys.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, said Zydus in a press release.

The group now has 328 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

USFDA gives nod to Strides Pharma for Amantadine HCL Softgel Capsules

USFDA gives nod to Lupin for sNDA for Solosec

USFDA gives nod to this Molecule to treat retinal vascular diseases

USFDA authorised Bebtelovimab as antibody drug

USFDA gives nod to Zydus for Roflumilast Tablets

USFDA gives nod to Lupin for Arformoterol Tartrate inhalation solution

IPA to organise 7th Global Pharmaceutical Quality Summit

BIS sets standard for these Medical Devices

The mandatory QR codes on APIs

NPPA fixes retail price of 19 formulations: February 2022

ICMR to conduct Clinical Trial for new drugs regimen for MDR TB

PCB issues directions to Pharma Companies to comply with norms

Police protection sought for Drugs Control Officers

USFDA gives nod to Lupin for sNDA for Solosec

India reports outbreak of H5N1 Bird Flu Virus

Latest Notifications regarding Pharmaceuticals

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