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:6/26/2016)... of Australia,s successful biotechnology scientists, Dr ... company, Noxopharm Limited [ABN 50 608 966 123] ("Noxopharm"). Noxopharm is ... the ASX. Noxopharm is a clinic-ready company with its ... clinical study later this year. ... facing cancer patients - the ability of cancers to become resistant ...
(Date:6/26/2016)... , June 27, 2016 Jazz Pharmaceuticals ... waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of ... acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: ... p.m. (Eastern Daylight Time). As previously announced ... into a definitive merger agreement under which Jazz Pharmaceuticals ...
(Date:6/26/2016)... Ontario , June 27, 2016  VMS Rehab ... Company,s Board will take whatever measures required to build ... Company,s stock which is currently listed on the OTC ... Wexler, Company Chairman and CEO, "We are seeing an ... difficult to understand, not only by the Company, but ...
Breaking Medicine Technology:
(Date:6/24/2016)... Dallas, Texas (PRWEB) , ... June 24, 2016 ... ... 12th International Conference and Scientific Sessions in Dallas that it will receive two ... Announcement of the grants came as PHA marked its 25th anniversary by recognizing ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Dr. Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile ... orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can ...
(Date:6/24/2016)... ... ... BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a ... an hour by 2020 and then adjusting it yearly to increase at the same rate ... assure the wage floor does not erode again, and make future increases more predictable. , ...
(Date:6/24/2016)... ... 2016 , ... EB Medicine presented its first-ever “Issue of ... in Ponte Vedra Beach, FL. The awards honor the outstanding work of leading ... and Pediatric Emergency Medicine Practice. , “With this award, we recognize the efforts ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... The Grove Investment Group (TGIG), has initiated cultivation and processing operations at its ... Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a complete system ...
Breaking Medicine News(10 mins):