Navigation Links
FDA Approves First Generic Versions of the Antibiotic Levofloxacin to Treat Certain Infections
Date:6/20/2011

SILVER SPRING, Md., June 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people ages 18 and older.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Levofloxacin is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.

"Generic drugs are important options that allow greater access to health care for Americans," said Keith Webber, Ph.D., deputy director, Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research. "FDA-approved generic drugs must meet rigorous standards and are required to be of high quality so that people can be assured that their medications will act the same in the body as the brand-name product."

Generic tablet, oral solution, and injectable solution dosage forms of levofloxacin have been approved. The following 12 manufacturer's applications for generic levofloxacin have been approved:

  • Akorn Inc.
  • Aurobindo Pharma Ltd.
  • Dr. Reddy's Laboratories Ltd.
  • Glenmark Generics Ltd.
  • Hi-Tech Pharmacal Co. Inc.
  • Lupin Ltd.
  • Mylan Pharmaceuticals Inc.
  • Sagent Strides LLC
  • Sandoz Inc.
  • Teva Pharmaceuticals USA
  • Torrent Pharmaceuticals Ltd.
  • Wockhardt Ltd.

Levofloxacin belongs to a class of drugs called fluoroquinolones. All fluoroquinolones have a boxed warning alerting prescribers and patients that these products are associated with an increased risk of tendinitis and tendon rupture. The risk is greater in older people, especially in those older than 60, in patients taking corticosteroid drugs, and in those with kidney, heart, or lung transplants. The boxed warning also contains an alert that the drug may worsen muscle weakness in people with myasthenia gravis, a chronic autoimmune neuromuscular disease.

Levofloxacin must be dispensed with a patient Medication Guide that describes the drug's uses and warnings.

For more information:


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Nulojix for Kidney Transplant Patients
2. FDA Approves New Test To Help Determine if Breast Cancer Patients Are Candidates for Herceptin Treatment
3. FDA Approves First Ceramic-on-Metal Total Hip Replacement System
4. FDA Approves Redesigned Labels for Some Merck Drugs
5. FDA Approves Updates to Lillys Humalog® (insulin lispro injection [rDNA origin]) Label
6. FDA Approves Marketing of RMS Subcutaneous Needle Sets
7. FDA Approves Injectable Gel to Treat Fecal Incontinence
8. FDA approves Incivek for hepatitis C
9. FDA Approves Sutent for Rare Type of Pancreatic Cancer
10. FDA Approves New HIV Treatment
11. FDA Approves Victrelis for Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/31/2016)... VALLEY COTTAGE, New York , May 31, 2016 ... traction as an essential ingredient in food, cosmetics and ... 2016 end, representing revenues worth US$ 1.6 Bn. ... vera gels, cosmetics products, juices, and yogurts will continue ... health and wellness trend will also boost positive sentiment ...
(Date:5/31/2016)... May 31, 2016 , Isansys  Lifecare, ... its Patient Status Engine wireless patient monitoring platform, as it ... Germany , Scotland and ... 2 nd generation system, launched earlier this year, is now ... , , This new technology significantly enhances ...
(Date:5/30/2016)... , May 30, 2016 ... report "Healthcare Biometrics Market by Technology (Single-factor ... Multifactor, Multimodal), Application (Workforce Management), End User ... 2021", published by MarketsandMarkets, the market is ... 2021 from USD 1,182.6 Million by 2016, ...
Breaking Medicine Technology:
(Date:5/31/2016)... (PRWEB) , ... May 31, 2016 , ... Splashtop Inc., ... its strategic partnership with e-Jan Networks Co., the leading provider of secure mobile ... customers of e-Jan Networks’s leading CACHATTO remote access solution. Splashtop for ...
(Date:5/31/2016)... ... May 31, 2016 , ... Twenty years ago it was revolutionary: enabling the ... silence the voices they hear. But this approach has proven transformative, both for people ... steadily gained credibility and now is used around the world, but it still lags ...
(Date:5/31/2016)... ... May 31, 2016 , ... ... Corporation, he knew it was something that contractors should have at their disposal ... it gets,” says Butch, CertainTeed’s Director of Contractor Programs. , As a ...
(Date:5/31/2016)... ... May 31, 2016 , ... CallTrackingMetrics's software gives ... monitor the performance of sales and support staff, and to efficiently route calls ... allows customers to record, transcribe, route, document, and report on everything going on ...
(Date:5/31/2016)... Newport Beach, Calif. (PRWEB) , ... May 31, 2016 , ... ... trust among colleagues, clients, and the industry as a whole. On June 2, Northbound ... Coast Symposium on Addictive Disorders (WCSAD) and presenting the opening plenary on “Leadership: The ...
Breaking Medicine News(10 mins):