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:9/30/2014)... Applying a well-known optical phenomenon called thin-film interference, ... demonstrated the ability to "paint" ultra-thin coatings onto ... for making future, flexible electronic devices, creating advanced ... rocket ships and spacecraft with extremely lightweight decorative ... water, it becomes iridescent, revealing a myriad of ...
(Date:9/30/2014)... analog of one of nature,s most efficient light-harvesting ... led by Alejandro Briseno of the University of ... developing long-sought polymer architecture to boost power-conversion efficiency ... devices. , Briseno, with colleagues and graduate ... University and Dresden University of Technology, Germany, report ...
(Date:9/30/2014)... 2014 Report Details Biosimilar drugs ... revenues Do you want to find sales potentials ... predictions for those biological drugs from 2014, helping ... financial data, R&D trends, opportunities and selling prospects. ... to 2024 at overall world market, therapeutic class, ...
(Date:9/30/2014)... Nematicide is a type of chemical ... parasitic roundworms, found in massive quantities virtually everywhere—in ... animals. Nematicides have tended to be broad-spectrum toxicants ... through the soil. A single gram of soil ... more than 10,000 species classified, they are one ...
Breaking Biology Technology:Taking thin films to the extreme 2Blades of grass inspire advance in organic solar cells 2Blades of grass inspire advance in organic solar cells 3Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024 2Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024 3Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024 4Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024 5Nematicides Market by Types (Fumigants, Organophosphates, Carbamate and Bio-Nematicides), Applications (Agrochemicals, Industrial, and Others), and Geography (North America, Europe, Asia-Pacific & ROW) - Global Trends & Forecasts to 2019 2
... The Gynecologic Cancer Foundation (GCF) and the Claudia Cohen Research Foundation announce today that ... $50,000 GCF/Claudia Cohen Prize for Outstanding Gynecologic Cancer Researcher.  The prize is being presented ... San Francisco March 14-17, 2010 . , ... ...
... has received a Paragraph IV Notice Letter,from Teva Pharmaceuticals USA, Inc. ("Teva") advising of the filing of an,Abbreviated New Drug Application ("ANDA") for ... ... , , ... ...
... Cylex™, a global life science company that develops and manufactures in vitro diagnostic products based on patented technology, announced today the expansion of ... , ... , , ... ...
Cached Biology Technology:Paul Goodfellow, PhD, Awarded First GCF/Claudia Cohen Prize for Outstanding Gynecologic Cancer Researcher 2Paul Goodfellow, PhD, Awarded First GCF/Claudia Cohen Prize for Outstanding Gynecologic Cancer Researcher 3Paul Goodfellow, PhD, Awarded First GCF/Claudia Cohen Prize for Outstanding Gynecologic Cancer Researcher 4Paul Goodfellow, PhD, Awarded First GCF/Claudia Cohen Prize for Outstanding Gynecologic Cancer Researcher 5Shire Receives INTUNIV (TM) Paragraph IV Notice Letter From Teva Pharmaceuticals 2Shire Receives INTUNIV (TM) Paragraph IV Notice Letter From Teva Pharmaceuticals 3Shire Receives INTUNIV (TM) Paragraph IV Notice Letter From Teva Pharmaceuticals 4Cylex Announces Valuable Personnel Additions 2Cylex Announces Valuable Personnel Additions 3Cylex Announces Valuable Personnel Additions 4Cylex Announces Valuable Personnel Additions 5
(Date:9/30/2014)... California, San Diego, have completed the first comprehensive numerical ... uses the pixels in an image as data points ... , The researchers, led by J.S. Chen, the William ... of Engineering at UC San Diego, presented their findings ... conference in Pittsburgh this month. Chen also gave a ...
(Date:9/30/2014)... Health (NIH) awarded Lawrence Livermore National Laboratory (LLNL) ... system that will enable researchers to better understand ... scale. , LLNL,s grant-funded project is part of ... (Brain Research through Advancing Innovative Neurotechnologies) Initiative , ... of the human mind and uncover ways to ...
(Date:9/30/2014)... Fish can live in almost any aquatic environment on ... up many species are pushed to the limit. The ... could prove critical for how different species cope in ... the University of Gothenburg, published in the scientific journal ... Climate change continues apace thanks to increasing levels of ...
Breaking Biology News(10 mins):First comprehensive meshfree numerical simulation of skeletal muscle tissue achieved 2NIH taps lab to develop sophisticated electrode array system to monitor brain act 2NIH taps lab to develop sophisticated electrode array system to monitor brain act 3Shape up quickly -- applies to fish, too! 2
... of modern human behaviour and technological advancement among our ... has taken a step closer to firmly establishing Africa, ... the early development of human behaviour. A new ... Henshilwood, is the first detailed summary of the time ...
... 5, 2012  In a partnership that brings new personalization ... is now enabling its members to transmit body monitoring ... their online trainers. The integration gives FitOrbit trainers access ... activity level and sleep pattern data that helps trainers ...
... Four University of Massachusetts Medical School faculty members ... the American Association for the Advancement of Science (AAAS), ... the journal, Science . They include: ... & physiological systems, who was elected to the section ...
Cached Biology News:Africa's Homo sapiens were the first techies 2BodyMedia & FitOrbit Up the Ante in Personalized Weight Loss 2BodyMedia & FitOrbit Up the Ante in Personalized Weight Loss 3UMass Medical School faculty elected to the American Association for the Advancement of Science 2
Mouse monoclonal [ICRF 44] to Integrin alpha M...
... Finnpipette Focus Long has a ... pipetting from test tubes, bottles, ... long necked vessels. Finnpipette Focus ... you select, it will be ...
... entire pressurized perfusion system for small ... biophysics, electrochemistry, or general liquid-handling research ... as 100 microliters of precious drugs. ... in milliseconds from a single tip. ...
Request Info...
Biology Products: