USFDA gives nod to Zydus for Chemotherapy drug

The drug will be manufactured at Zydus Hospira, Gujarat, the company said.

318
USFDA Drug product Approval
USFDA Approval

Last Updated on December 31, 2023 by The Health Master

Zydus Lifesciences said it has received final approval from the US health regulator to market Pemetrexed for injection used to treat certain types of cancers.

The approval granted by the US Food and Drug Administration (USFDA) is for Pemetrexed for injection, in strengths of 100 mg/vial, 500 mg/vial, and 1,000 mg/vial of single dose, the company said in a regulatory filing.

Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma.

It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells, it added.

The drug will be manufactured at Zydus Hospira, Gujarat, the company said.

Citing IQVIA MAT March 2022 data, the company said Pemetrexed for injection had a market size of USD 1.23 billion.

The group now has 314 approvals and has filed over 400 abbreviated new drug applications since the commencement of the filing process in 2003-04.

USFDA issues final approval to Alembic for Pirfenidone tablets

USFDA gives nod to Glenmark for Abiraterone Acetate tablets USP 500 mg

USFDA approves Oral Form for the treatment of Amyotrophic lateral sclerosis (ALS)

USFDA gives nod to Sun Pharma Mesalamine extended release capsules

USFDA gives approval to Alembic Pharma for Arformoterol Tartrate Inhalation Solution

USFDA gives tentative nod to Glenmark for Calcipotriene and Betamethasone Dipropionate foam

Guidelines meant to stop cross Pathy by Doctors

New Clinical Trial: 1st human patient injected with Cancer-killing virus

USFDA declines to approve this Anti-seizure drug

AIOCD seeks 10% trade margin for wholesalers & 20% for retailers

Govt to relax conditions on liquid antiseptics under Schedule K

Govt: Draft notification to add 16 drugs as OTC under Schedule K of Drugs Rules

USFDA declines to authorise this viral skin disease treatment

Govt to amend Drugs Rules 1945 for parallel submission of marketing and manufacturing approvals

After blood transfusion, 4 children become HIV positive, FDA starts investigation

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

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