Navigation Links
Mylan's Matrix Receives FDA Approval Under PEPFAR for Zidovudine Tablets, 100 mg
Date:3/10/2011

PITTSBURGH, March 10, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Zidovudine Tablets, 100 mg. The NDA is based on the reference listed drug Retrovir® Tablets, by ViiV Healthcare. This pediatric antiretroviral (ARV), the first of its kind in water-dispersible tablet form, was developed by Matrix for use in treating children with HIV/AIDS and in prevention of mother-to-child HIV transmission. This product will be eligible for purchase outside the U.S. in certain developing countries.

Mylan President Heather Bresch said: "According to PEPFAR, prevention of mother-to-child transmission (PMTCT) of HIV is extraordinarily effective. Without PMTCT, 25 to 40% of babies of HIV-positive mothers will be born infected; with PMTCT, that number drops to below 5%. With the approval of Zidovudine Tablets we are not only able to help treat children with HIV/AIDS in developing countries, but we are also able to help prevent HIV transmission before a child is even born. The approval of Zidovudine Tablets is a critical next step in helping to achieve UNAIDS' goal to eliminate mother-to-child transmission by 2015. With every generic ARV we bring to market we expand access to high quality, affordable HIV/AIDS medication in developing countries."

Zidovudine Tablets are used in combination with other medications to control HIV infection and also are used for the prevention of mother-to-child HIV-1 transmission. The product is included in the ARV class of drugs known as nucleoside reverse transcriptase inhibitors. The FDA's approval under PEPFAR means that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.
'/>"/>

SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Cardium Reports Excellagen Matrix Clinical Study Results Accepted for Publication by Peer-Reviewed Journal, and Updates Product Plans
2. BioNanomatrix Founder and CSO Dr. Han Cao Awarded Chinese Rising Star Entrepreneur Award
3. Collagen Matrix, Inc. Receives FDA 510(k) Clearance for New Collagen Dental Membrane Based on Porcine Collagen Platform Technology
4. Human Embryonic-Like Extracellular Matrix Significantly Inhibits Tumor Growth and Cancer Cell Proliferation
5. TriReme Medical, Inc. Receives FDA 510(k) Clearance for a Broad Matrix of GliderXtreme(TM) PTA Balloon Catheter Sizes
6. Matrix Corporate Capital and PharmaVentures Announce the Signing of a Memorandum of Understanding (MOU)
7. TEI Biosciences PriMatrix(TM) Awarded Seal of Approval by American Podiatric Medical Association
8. Osteotech Submits 510(k) Application to FDA for Clearance of its Duratech(TM) BioRegeneration Matrix
9. BioNanomatrix Awarded Supplemental Funding to Accelerate Commercialization of Innovative Single-Molecule Analyzer
10. Brennen Medical Announces Sale of XenMatrix(R)
11. BioNanomatrix Appoints Genomic Research Experts Charles Lee and David L. Barker as Advisers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... 2014 AudioNotch is the internet's leading ... the treatment of tinnitus. Patients listen to sound therapy ... a period of weeks to months, their tinnitus volume decreases. ... forms: Notched Music and Notched White Noise. Now, AudioNotch is ...
(Date:1/14/2014)... January 14, 2014 Date: Friday, April 11, ... Warrington Country Club, 1360 Almshouse Road, Warrington, Pa. ... organization solely dedicated to finding a cure for hepatitis B ... will host its annual Crystal Ball on Friday, April 11 ...
(Date:1/14/2014)... 2014 Histogen, Inc., a regenerative medicine ... grown under simulated embryonic conditions, today announced that they ... Medical, Inc. for physician-dispensed aesthetic products containing Histogen’s proprietary ... agreement is an amendment to the existing license between ...
(Date:1/14/2014)... BURLINGAME, Calif. , Jan. 14, 2014 As pet owners ... no doubt many of them wrote: "Take better care of my ... and even designer clothes and top-brand carrying cases to take the ... Pet parents might also feel compelled to buy some pricey toys ...
Breaking Biology Technology:Hepatitis B Foundation to Host Annual Crystal Ball Gala 2Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally 2Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally 3New Year's Resolution: Give Pets the Gift of Top-Notch Health Care 2
... a regulatory framework to guide the approval of the ... providing more affordable treatment for millions of Americans suffering ... chairman and CEO of Medco Health Solutions, Inc. (NYSE: ... and innovation over a period of many years has ...
... CASTLE, Del., March 12 -- Arkion(R) Life Sciences has ... AV-1011 Liquid Rice Seed Treatment in Louisiana and Missouri ... The EPA approval means that rice growers in these ... grackles. The new bird repellent effectively stops birds ...
... States, long the beneficiary of talented immigrants, must act ... pursue expanding opportunities in their home countries, according to ... Science and Technology .In A Reverse Brain Drain ... Harvard Law School, writes that immigrant scientists and engineers, ...
Cached Biology Technology:Biogenerics Legislation Provides Critical Pathway to Affordable Access for Patients with Chronic and Complex Conditions 2Biogenerics Legislation Provides Critical Pathway to Affordable Access for Patients with Chronic and Complex Conditions 3AV-1011 Bird Repellent to Protect Rice Seed Approved for Use in Louisiana and Missouri 2U.S. Risks Losing Highly Skilled Immigrants 2U.S. Risks Losing Highly Skilled Immigrants 3
(Date:4/23/2014)... announced Sophie Martin of the University of Lausanne, Switzerland, ... The award acknowledges her work to understand the molecular ... cell. , Martin has been working for the past ... way in which the spatial organization of cells contributes ... 11 years, she has been using fission yeast, which ...
(Date:4/23/2014)... new study by a University of Exeter researcher has ... of wild camels thriving in Australia,s remote outback have ... scale. , Sarah Crowley, of the Environment and Sustainability ... the history of the camel in Australia, from their ... to their current status as unwelcome "invader." , The ...
(Date:4/23/2014)... a technique used to read quickly. It involves ... non-essential words and/ or sentences. Similarly to humans, ... quickly "read" genetic information. Genes that need to ... smaller the encoding message, the easier it will ... Instituto Gulbenkian de Cincia (IGC, Portugal) and Centre ...
Breaking Biology News(10 mins):EMBO Gold Medal 2014 awarded to Sophie Martin 2How Australia got the hump with 1 million feral camels 2How Australia got the hump with 1 million feral camels 3Cell division speed influences gene architecture 2
... from North Carolina State University, the University of Washington ... most diverse collections of prehistoric non-native animal remains in ... find contributes to our understanding of culture in the ... may have been more important than previously thought. ...
... The Saint Louis Zoo,s Ron Goellner Center for ... on Nov. 30, 2011, that Ozark hellbenders have been ... subspecies of hellbender. This decade-long collaboration has yielded ... Nov. 15, and currently there are approximately 120 additional ...
... COPENHAGEN, DENMARK/ROCKVILLE, MD, USA Statens Serum Institut and Aeras ... trial of a new candidate TB vaccine designed to protect ... The trial is being conducted by the South African ... in the Western Cape province of South Africa. Dr. Hassan ...
Cached Biology News:Archaeologists find new evidence of animals being introduced to prehistoric Caribbean 2World's first captive breeding of Ozark hellbenders at Saint Louis Zoo 2World's first captive breeding of Ozark hellbenders at Saint Louis Zoo 3Vaccine targeting latent TB enters clinical testing 2
Sigmas E-TOXATE (Limulus Amebocyte Lysate) test kits are intended for the detection and semiquantitation of endotoxins for research purposes. sensitivity 0.05-0.1 EU/mL...
... The Label IT siRNA Tracker Intracellular Localization ... directly label and deliver siRNA, of your ... for in vitro tracking experiments. Subcellular localization ... can be monitored following introduction of the ...
... MW: 60kDa (A) and 36kDa (C) ... pH 7.5, 500mM NaCl, 60mM 2-mercaptoethanol, ... 1mM DTT, and 0.1mg/ml serum albumin ... of proteins. Purification: DEAE chromatography, aminohexyl-agarose ...
... The Label IT siRNA Tracker Intracellular ... to directly label and deliver siRNA, of ... manner, for in vitro tracking experiments. Subcellular ... expression can be monitored following introduction of ...
Biology Products: