Unichem gets tentative USFDA nod for drug to treat Diabetes

This approval is for a generic version of Januvia (sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharpe and Dohme Corp (Merck).

252
USFDA Approval
USFDA Approval

Last Updated on October 17, 2024 by The Health Master

Unichem Laboratories has received tentative approval for ANDA of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United States Food and Drug Administration (USFDA)

This approval is for a generic version of Januvia (sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharpe and Dohme Corp (Merck).

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The product will be commercialised from Unichem’s Goa Plant on receipt of full approval.

Alembic gets USFDA final nod for Erlotinib Tablets

Alembic gets USFDA nod for drug for the treatment of Depression

USFDA approves Abbott’s Stent to treat high bleeding risk patients

Zydus Cadila gets USFDA nod for drug to treat HIV infection

Alembic gets USFDA nod for Nitrofurantoin Capsules USP

Axio Biosolution gets USFDA nod for Patch for bleeding control

All Legislation of India (for Pharma and Health professionals)

Latest Notifications: General (Pharmaceuticals)

Webinar held on Investigational skills for Drug regulators of India

CDSCO to API units: To file online applications on Sugam Portal

Delhi High Court set up IPD for Pharma Industry

Fake Favipiravir racket busted: FIR lodged

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