Last Updated on March 9, 2024 by The Health Master
CDSCO approval
In a significant development, Cipla has received CDSCO approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic plazomicin in India.
This breakthrough brings a promising solution for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, addressing a global health problem affecting approximately 150 million patients each year.
Understanding Plazomicin
1. The Significance of Plazomicin
Plazomicin is a new Intravenous (IV) aminoglycoside, proving to be a crucial addition to the medical arsenal for combating complicated urinary tract infections.
2. Global Impact of UTIs
The prevalence of UTIs worldwide and the emergence of drug-resistant uropathogens underscore the urgent need for effective treatments like plazomicin.
Clinical Efficacy and Safety
3. Pivotal Clinical Trial
A pivotal clinical trial showcased the efficacy and safety of plazomicin, setting it apart as a reliable treatment option.
4. In-vitro Studies
In-vitro studies further validated plazomicin’s effectiveness, particularly when compared to meropenem, a commonly used antibiotic.
5. Addressing Drug Resistance
Highlighting its unique quality, plazomicin demonstrated the ability to retain in-vitro activity against strains resistant to older aminoglycosides, a crucial factor in managing antibiotic resistance.
Cipla’s Role and ZEMDRI
6. Cipla USA and Patent Rights
Cipla USA, a subsidiary of Cipla, holds the patent for plazomicin sulfate, solidifying its position as an innovator in the pharmaceutical industry.
7. Global Market Presence
Cipla possesses global rights for plazomicin, excluding Greater China, and markets the product in the USA under the brand name ZEMDRI.
8. USFDA Approval
ZEMDRI received USFDA approval from the in 2018, attesting to its safety and efficacy.
9. New Technology Add-On Payment (NTAP) Status
ZEMDRI’s designation as a new technology add-on payment (NTAP) by the US Medicare and Medicaid Services highlights its importance in hospital administration.
Leadership Perspective
10. Umang Vohra’s Statement
Umang Vohra, Managing Director, and Global CEO of Cipla, emphasized the significance of introducing plazomicin in India.
He highlighted Cipla’s commitment to addressing healthcare challenges and countering the global threat of Antimicrobial Resistance (AMR).
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
CDSCO approval granted for this Breakthrough Antidote
CDSCO approval granted for Clinical Trials of XBB.1.5 Vaccine
CDSCO approval granted for this breast cancer treatment drug
CDSCO approval granted for Inhalation Aerosol: AstraZeneca
CDSCO approval granted to study High BP Drug Baxdrostat
15 Vaccines and 5 booster doses approved so far in India: CDSCO
Tamil Nadu: The Restructuring of (DCA) Drugs Control Administration
Beyond Paperwork: CDSCO’s Bold Move to Online PSUR Submissions
A Crucial Amendment: Revolutionizing Surrogacy Rules
Gujarat FDCA seized Fake Drugs worth Rs. 1.75 crore
Regulator’s Guide: Mastering the Art of Effective Drug Sample Collection for Analysis
Ban: Hookah Serving to be a Punishable Offense in Haryana
FOPE: Impact of revised Schedule M on Pharma and Nutraceuticals
IPC issues Draft Pharmacovigilance Guidance Document for Pharmaceuticals
Behind the Scenes: Decoding Leadership in India’s API Industry
Illegal Plasma Trade: DCA Telangana Takes Action on Blood Centres
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
