USFDA gives nod to these companies for Bortezomib for injection

Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma.

280

Last Updated on December 31, 2023 by The Health Master

Zudus

Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to market Bortezomib for injection, 3.5 mg/vial, single-dose vial, a company statement notified.

Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma.

The medication works by slowing or stopping the growth of cancer cells. The drug will be manufactured at Zydus Hospira, the statement added.

Aurobindo

Aurobindo Pharma on Tuesday said its wholly-owned arm Eugia Pharma Specialties Ltd has received final approval from the US health regulator to manufacture and market its generic version of Bortezomib for injection used to treat certain types of cancer.

The approval by the US Food and Drug Administration (USFDA) is for single-dose vial of Bortezomib for injection of strength 3.5 mg/vial, Aurobindo Pharma said in a regulatory filing. The product is the generic version of reference listed drug Velcade of Takeda Pharmaceuticals USA Inc.

The product is being launched immediately, it added.

Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma (cancer of plasma cells) and is also used to treat adult patients with mantle cell lymphoma (cancer of lymph nodes), the company said.

The approved product has a market size of USD 1.172 billion for the 12 months ended March 2022, the company said citing IQVIA data.

USFDA grants approval for drug to treat spondylitis

USFDA approves this oral heart disease drug

USFDA gives tentative nod to Alembic Pharma for Ivabradine tablets

USFDA gives nod to Lupin for Desvenlafaxine ER tablets

USFDA authorises first C-19 diagnostic test using breath samples

USFDA gives approval to Aleor for Lidocaine & Prilocaine cream

USFDA grants approval for drug to treat spondylitis

A smarter way to develop new drugs

DCGI extends timeline for Pharma Firms to regularize 294 FDCs

Medical Degrees from Pakistan declared invalid by NMC

Himachal Pharma firms battle higher input costs

Medical Degrees from Pakistan declared invalid by NMC

USFDA approves this oral heart disease drug

E-Pharmacy market in India to grow at 45% in future: Report

Drug alert: 48 out of 1454 samples declared as NSQ in March 2022

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