Navigation Links
Mylan's Matrix Receives Tentative FDA Approval Through PEPFAR for Novel "Co-Packaged" Version of HIV/AIDS Treatment
Date:9/20/2011

PITTSBURGH, Sept. 20, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300 mg/300 mg, co-packaged with Nevirapine Tablets, 200 mg. The product will be eligible for purchase outside the U.S. in certain developing countries.

(Photo:  http://photos.prnewswire.com/prnh/20110920/NE71136)

Mylan President Heather Bresch said: "The approval of Lamivudine / Tenofovir Disoproxil Fumarate Tablets co-packaged with Nevirapine Tablets is an important product developed by Matrix for the treatment of HIV/AIDS. For the first time, it makes available a co-pack option that can help patients with the carrying and storage of this critical first-line ARV cocktail. Co-packs are convenient and may help to facilitate patient compliance with what often can be part of a burdensome drug regimen for HIV/AIDS patients managing many prescriptions and therapies."

This product offering is the first generic ARV drug product in a co-pack form and can be used alone or in combination with other ARVs for the treatment of HIV/AIDS. The FDA's tentative approval through PEPFAR signifies that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.

Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are the generic versions of GlaxoSmithKline's Epivir®, Gilead Sciences' Viread® and Boehringer Ingelheim's Viramune®, respectively. This particular co-pack of ARV products also is suitable for the treatment of pregnant women with HIV/AIDS in certain countries where Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are approved for use during pregnancy. Nevirapine is preferred over other drugs in the same class, such as Efavirenz, for pregnant women with HIV/AIDS.

Matrix's wide range of ARV products includes active pharmaceutical ingredients and 36 first- and second-line finished doses, eight 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 medicine technology :

1. Use of TIGR® Matrix Surgical Mesh in Multi-Center Randomized Controlled TRAM Flap Study Passes 20 Patient Mark and Wins Praise from Participating Surgeons
2. Healthpoint Biotherapeutics Introduces OASIS® Ultra Tri-Layer Matrix
3. TIGR® Matrix Surgical Mesh - Exhibited Ahead of Anticipated CE Mark Approval at European Hernia Society 2011, Ghent, Belgium
4. Positive Findings From Excellagen Matrix Clinical Study Published in Peer-Reviewed Journal Wound Repair and Regeneration
5. Perrigo Enters Into Exclusive Sales and Distribution Agreement With AgaMatrix for Store Brand Blood Glucose Monitoring Products
6. Mylans Matrix Obtains License for Promising HIV/AIDS Treatment
7. Surgeons at University of California San Diego Perform 1st TRAM Flap Procedure in an International Multi-Center Study Using TIGR® Matrix Surgical Mesh, the Worlds 1st Long-Term Resorbable Mesh
8. Mylans Matrix Receives Approval for Generic Version of Protonix® Delayed-release Tablets
9. Matrixx Initiatives, Inc. Announces End of Go-Shop Period
10. Matrixx Initiatives, Inc. Summarizes Ongoing Go-Shop Process and Board Reaffirms Recommendation
11. Matrixx Initiatives, Inc. Reports Fiscal 2011 Third Quarter Net Sales of $20.3 Million and Net Loss of $11.3 Million, or $(1.21) Per Share
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Research and Markets has announced the ... 2016 - Forecast to 2022" report to their offering. ... up to date financial data derived from varied research sources ... with potential impact on the market during the next five ... comprises of sub markets, regional and country level analysis. The ...
(Date:6/23/2016)... -- Bracket , a leading clinical trial technology and ... platform, Bracket eCOA (SM) 6.0, at the 52 nd ... 2016 in Philadelphia , Pennsylvania.  A demonstration ... of its kind to fully integrate with RTSM, will be ... is a flexible platform for electronic clinical outcomes assessments that ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology:
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/24/2016)... ... , ... A recent article published June 14 on E Online ... on to state that individuals are now more comfortable seeking to undergo not only ... calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
(Date:6/24/2016)... ... 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join ... wage raise to $12 an hour by 2020 and then adjusting it yearly to increase ... of the minimum wage, assure the wage floor does not erode again, and make future ...
Breaking Medicine News(10 mins):