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,
'/>"/>

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

Page: 1 2

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:7/29/2015)... YORK , July 29, 2015 /PRNewswire/ ... a new research report "Global Industry Insight: ... to 2020" with market overview, trends, DRO analysis, ... analysis, recent developments, competitive scenario and top ... http://photos.prnewswire.com/prnh/20150727/756778 ) Microfluidic devices  ...
(Date:7/29/2015)... LONDON , July 29, 2015 ... the Novartis transaction closed, CFO Simon Dingemans ... acquired businesses are performing in line with expectations. Ahead ... company,s commitment to sustainable innovation. The interview ... MerchantCantos produces in-depth interviews, documentaries and webcasts ...
(Date:7/29/2015)... , July 29, 2015  Cepheid (Nasdaq: ... an update to Xpert® Carba-R, with the addition ... OXA-232.  The on-demand, molecular test also detects and ... carbapenem resistance, namely KPC, NDM, VIM, IMP-1 and ... as CROs or Superbugs, are a growing and ...
Breaking Medicine Technology:Global Microfluidic Devices Market (Size of $1,886 Million in 2014) to Witness a CAGR of 23% During 2015 - 2020 2Global Microfluidic Devices Market (Size of $1,886 Million in 2014) to Witness a CAGR of 23% During 2015 - 2020 3Global Microfluidic Devices Market (Size of $1,886 Million in 2014) to Witness a CAGR of 23% During 2015 - 2020 4Global Microfluidic Devices Market (Size of $1,886 Million in 2014) to Witness a CAGR of 23% During 2015 - 2020 5'Superbug' Test Updated to Identify Newest Carbapenem-Resistant Organisms 2'Superbug' Test Updated to Identify Newest Carbapenem-Resistant Organisms 3'Superbug' Test Updated to Identify Newest Carbapenem-Resistant Organisms 4
... YORK, June 22, 2011 (Digital Experience!) -- iHealth ... personal healthcare products including the iHealth BP3 Blood Pressure ... announced that multiple national retail chains will now distribute ... Pressure Monitoring System is now available in all Apple ...
... Cempra Pharmaceuticals Inc. today announced that Prabhavathi ... the 2011 Wells Fargo Healthcare Conference at 1 p.m. ... provide an overview of the company,s two leading antibiotic ... infections and TAKSTA™ for the oral treatment of gram ...
Cached Medicine Technology:iHealth Lab's Blood Pressure Self-Monitoring System Gets Nationwide Distribution 2
(Date:7/29/2015)... , ... July 29, 2015 , ... It is unique ... “This is a tremendous model of care. One that is very hands on and ... executive director of Monarch Landing. “She’s bringing great passion and energy, as well as ...
(Date:7/29/2015)... ... July 29, 2015 , ... Stealth ... a Clinical Performance Study for the Invisiport at Wheaton Franciscan Healthcare in Milwaukee, ... options, offers a less invasive, patient-friendly alternative to traditional chest ports and peripherally ...
(Date:7/29/2015)... ... ... TransFlip is an all new dynamic transition pack for FCPX, containing flipping ... are easy to apply and modify for any skill-level user. TransFlip includes custom bounce ... kinetic flipping panel animations are just a few clicks away. , TransFlip contains over ...
(Date:7/29/2015)... ... July 29, 2015 , ... Zofran lawsuits around the ... Multidistrict Litigation (JPML), according to court documents.* Attorneys handling Zofran lawsuits ... Birth Defects Lawsuit Center. , GlaxoSmithKline, the global pharmaceutical conglomerate and defendant in ...
(Date:7/29/2015)... , ... July 29, 2015 , ... The New ... project, which will by the end will cost the 501(c) organization nearly $1 million, ... recent anti-ligature requirements. , “We took it down to the studs,” said Geraldine ...
Breaking Medicine News(10 mins):Health News:New Medical Director Readies To Take Reins at Monarch Landing 2Health News:New Medical Director Readies To Take Reins at Monarch Landing 3Health News:Stealth Therapeutics Inc. Enrolls First Patients in a Clinical Performance Study for the Invisiport Product Line 2Health News:Stealth Therapeutics Inc. Enrolls First Patients in a Clinical Performance Study for the Invisiport Product Line 3Health News:Pixel Film Studios Releases FCPX Transition TransFlip for FCPX 2Health News:Zofran Lawsuit News: Zofran Lawsuits Stayed, Awaiting MDL Decision 2Health News:Zofran Lawsuit News: Zofran Lawsuits Stayed, Awaiting MDL Decision 3Health News:Zofran Lawsuit News: Zofran Lawsuits Stayed, Awaiting MDL Decision 4Health News:The New Foundation AZ Renovates Residential Dorms for Youth in Crisis 2Health News:The New Foundation AZ Renovates Residential Dorms for Youth in Crisis 3
... takes a complete snapshot of adolescent cardiovascular health in the ... likely to die of heart disease at a younger age ... "We are all born with ideal cardiovascular health, but ... health in youth," said Donald Lloyd-Jones, M.D., chair and associate ...
... is the recipient of one of Canada,s top awards ... the mammalian immune system, Kubes will accept the 2011 ... Canadian Institutes of Health Research (CIHR) at a ceremony ... Kubes for winning this prestigious award," said the Honourable ...
... Like a gardener who stakes some plants and weeds ... synapses, while pruning out redundant or unneeded synapses. Researchers ... Zhang, Ph.D., have discovered a factor in synapse-building, also ... of each other. Mammals are born with functioning ...
... The American Academy of Orthopaedic Surgeons (AAOS) Board of ... practice guideline (CPG) on "The Treatment of Supracondylar Humerus ... surgeon, medical director of the Trauma Program at the ... chair of the AAOS Work Group responsible for this ...
... Aging Society and Services and Advocacy for GLBT ... acclaimed Public Policy & Aging Report (PPAR) on ... policy and research on LGBT older adults, and current and ... "Given the voluminous gerontological literature that has built up over ...
... less produce the finest foie gras that rich, buttery ... eaten as slices atop lightly toasted bread scientists are ... and Food Chemistry. Caroline Molette and colleagues explain ... gras, a traditional French dish, comes from its high fat ...
Cached Medicine News:Health News:Today's teens will die younger of heart disease 2Health News:Today's teens will die younger of heart disease 3Health News:University of Calgary researcher named Canada's Health Researcher of the Year 2Health News:University of Calgary researcher named Canada's Health Researcher of the Year 3Health News:Jackson Laboratory researchers uncover steps in synapse building, pruning 2Health News:AAOS issues new clinical practice guideline for treating common elbow fractures in children 2Health News:New report highlights LGBT older adults' needs, identifies policy opportunities 2
For the quantitative in vitro determination of Uric Acid in serum, plasma and urine...
For the quantitative in vitro determination of apolipoprotein A-1 (apo A-1) in serum and plasma. For use as an aid if assessing the risk of coronary artery disease....
For the quantitative in vitro determination of Urea in serum, plasma and urine....
The XTRI method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of triglycerides in serum and plasma....
Medicine Products: