Zydus Cadila gets tentative USFDA nod for Osimertinib Tablets

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

138
USFDA Approval
USFDA Approval

Last Updated on October 11, 2024 by The Health Master

Zydus Cadila has received tentative approval from the USFDA to market Osimertinib Tablets in the strengths of 40 mg and 80 mg (US RLD: Tagrisso Tablets). Osimertinib is used to treat lung cancer.

Medicine
Picture: Pixabay

It belongs to a class of drugs known as kinase inhibitors. Osimertinib works by slowing or stopping the growth of cancer cells. It binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumours.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 318 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila gets USFDA nod for Fluphenazine HCL Tablets

Glenmark gets USFDA nod for Icatibant injection single-dose prefilled syringe

NATCO Pharma gets USFDA nod for Everolimus tablets

Natco Pharma gets USFDA nod for Lenalidomide capsules

Unichem Labs gets USFDA approval for Amitriptyline HCL Tablets

Alembic gets USFDA Final nod for Lurasidone HCL Tablets

Green signal: Moderna vaccines may soon be available in India

Drug alert: 23 out of 931 samples declared as NSQ in…

Govt issues operational guidelines for Pharma PLI scheme

USFDA accepts application from Lupin for Pegfilgrastim Biosimilar

Sun Pharma, Ferring Pharma sign agreement to launch CARITEC in India

Glenmark launches drug for the treatment of seizures

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