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:12/5/2016)... TAIPEI, Taiwan , Dec. 5, 2016 ... alfa-2b showed non-inferiority to hydroxyurea (HU) in Complete Hematologic Response ... and tolerability profile of ropeginterferon alfa-2b versus HU ... ongoing long-term follow-up trial CONTINUATION-PV to obtain European marketing authorization ... present this data to the FDA as it seeks approval ...
(Date:12/4/2016)... SAN DIEGO , Dec. 3, 2016 Johnson ... filed on behalf of purchasers of Zimmer Biomet Holdings, Inc. ... September 7, 2016 through October 31, 2016 (the "Class Period"). ... It designs, manufactures, and markets orthopaedic reconstructive products, such as ... ...
(Date:12/4/2016)... 3, 2016   Pairnomix, LLC, a genetic research ... recognized by the White House, today announced that findings from ... identification of candidate therapies for a patient with epileptic encephalopathy ... were presented at the 70 th Annual Meeting of ... TX , December 2-6, 2016.  Pairnomix, unique ...
Breaking Medicine Technology:
(Date:12/5/2016)... ... 05, 2016 , ... BSI and Brenntag Canada have been appointed by Chr. ... of their natural fruits and beverage colorants effective November 1, 2016. ... our Life Sciences product portfolio,” said Steve Brauer, President of Brenntag Specialties, Inc. “Representing ...
(Date:12/5/2016)... , ... December 05, 2016 ... ... Great Point Partners ("GPP") portfolio company, today announced it has acquired the ... TCS was previously a subsidiary of Chiltern International and focuses on ...
(Date:12/5/2016)... ... ... The new knee compression sleeves come as a pair which will provide ... lifting and any sport that requires knee compression or protection from the demands ... higher quality knee sleeve performance. Firstly it is made out of premium 7mm thick ...
(Date:12/5/2016)... OH (PRWEB) , ... December 05, 2016 , ... ... engineering solution called the CardioQuick Patch® significantly improves the reproducibility and accuracy of ... in various healthcare settings. , Over the last 60 years, studies have ...
(Date:12/4/2016)... ... December 03, 2016 , ... ... "Best Surgical Body Shaping" at the 2016 Anti-Aging & Beauty Awards ... , The Aesthetic & Anti-Aging Medicine European Congress (AMEC) brings together ...
Breaking Medicine News(10 mins):