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. The water-dispersible tablet is unique because it can be dispersed in water for all patients, adults or children, who are unable to swallow tablets.

Matrix's wide range of ARV products includes active pharmaceutical ingredients and 35 first- and second-line finished doses, nine of which are pediatric products. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries depend on a Matrix ARV product.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

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:10/11/2017)... ... October 11, 2017 , ... A new ... rates in frozen and fresh in vitro fertilization (IVF) transfer cycles. ... to IVF success. , After comparing the results from the fresh and frozen ...
(Date:10/10/2017)... ... October 10, 2017 , ... San Diego-based team building and cooking events company, ... today. The bold new look is part of a transformation to increase awareness, ... significant growth period. , It will also expand its service offering from its signature ...
(Date:10/10/2017)... ... October 10, 2017 , ... For the second ... a US2020 STEM Mentoring Award. Representatives of the FirstHand program travelled to Washington, ... from US2020. , US2020’s mission is to change the trajectory of STEM education ...
(Date:10/10/2017)... firm Parks Associates announced today that Tom Kerber , ... Meeting , October 11 in Scottsdale, Arizona . Kerber ... smart safety and security products impact the competitive landscape. ... Parks Associates: Smart Home Devices: Main Purchase Driver ... "The residential security market has experienced continued growth, and the introduction ...
Breaking Biology Technology:
(Date:4/19/2017)... 2017 The global military biometrics ... marked by the presence of several large global players. ... five major players - 3M Cogent, NEC Corporation, M2SYS ... nearly 61% of the global military biometric market in ... global military biometrics market boast global presence, which has ...
(Date:4/11/2017)... GARDENS, Fla. , April 11, 2017 /PRNewswire/ ... management and secure authentication solutions, today announced that ... by Intelligence Advanced Research Projects Activity (IARPA) to ... IARPA,s Thor program. "Innovation has been ... and IARPA,s Thor program will allow us to ...
(Date:4/5/2017)...  The Allen Institute for Cell Science today announces ... portal and dynamic digital window into the human cell. ... application of deep learning to create predictive models of ... a growing suite of powerful tools. The Allen Cell ... publicly available resources created and shared by the Allen ...
Breaking Biology News(10 mins):