Navigation Links
Mylan's Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla(R) HIV Treatment
Date:8/18/2009

PITTSBURGH, Aug. 18 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that Matrix Laboratories, an Indian company in which Mylan owns a controlling stake, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for a fixed-dose combination (FDC) of Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Tablets, 600 mg/200 mg/300 mg. This is the first and only generic version of this product and will be eligible for purchase outside the U.S. in many developing countries.

Mylan President Heather Bresch said: "This critical approval only further strengthens Mylan and Matrix's efforts to expand access to life-saving, affordable AIDS treatments for people living with HIV/AIDS in developing countries. Matrix's generic fixed-dose combination will dramatically improve access to this more patient-friendly medication while reducing the cost of treatment. Our commitment to growing Matrix's ARV (antiretroviral) franchise goes hand-in-hand with our desire to raise the standard of care in developing countries to the levels available in countries like the U.S."

The Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate FDC is the generic version of Gilead Sciences' Atripla(R) Tablets, which are indicated for the treatment of HIV-1 infection in adults. It combines three anti-AIDS medicines into a single daily dose for either first- or second-line treatment and is one of the best-selling AIDS products in developed countries, with approximately $1.6 billion in U.S. sales alone for the twelve months ending June 30, according to IMS Health. Until now, a generic version of this product has not been available in any market. Cocktails combining numerous drugs into a once daily dose can dramatically reduce pill burden, an improvement which has been shown to enhance patient compliance with complex treatment regimens.

The FDA's tentative approval under PEPFAR means that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards. Although existing patents or exclusivity prevent its marketing in the U.S., the product will be eligible for purchase outside the U.S. in many developing countries.

Matrix's wide range of ARV products includes active pharmaceutical ingredients (API) and first- and second-line finished doses. 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 at least one Matrix ARV product.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Sigma-Aldrich Offers Customizable Synthetic Extracellular Matrix for Stem Cell Research
2. Matrixx Initiatives, Inc. Sets Time for Discussion of First Quarter Fiscal 2010 Financial Results
3. MedInsights Partners With myMatrixx(TM) for Workers Compensation Pharmacy Benefit Management
4. Matrixx Initiatives Confirms Voluntary Recall of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs
5. Matrixx Initiatives, Inc. Sets Time for Discussion of Recent FDA Action
6. Matrixx Initiatives Voluntarily Withdraws Zicam Cold Remedy Swabs, Zicam Cold Remedy Nasal Gel
7. Matrixx Initiatives, Inc. Received a Warning Letter From the Food and Drug Administration
8. Mylan Announces Successful Matrix Delisting Offer
9. Cardium Presents Gene Activated Matrix Technology and Update on Excellarate Clinical Development Program at ASGT Annual Meeting
10. Matrixx Initiatives, Inc. Reports Fiscal 2009 Revenue Increased 11% to a Record $111.6 Million and Earnings Per Share Increased 40% to $1.46
11. CorMatrix Cardiovascular to Present on its ECM Technology(TM) at the Annual Advanced Cardiac Techniques in Surgery (ACTS) Symposium in New York, N.Y.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... ... 28, 2016 , ... Greener Hydroponics is now offering a large selection of ... professional organic farmers and nurseries according to Sales Manager Joe Steele who says, “Now ... goal is to offer wholesale level pricing and ultra-fast shipping for growers of any ...
(Date:4/28/2016)... ... April 28, 2016 , ... In 2011, TIME magazine named Herr ... field of biomechatronics, technology that marries human physiology with electromechanics. He continues that work ... also the Founder of BionX , a leader in the field of prosthetic ...
(Date:4/28/2016)... (PRWEB) , ... April 28, ... ... leading provider of enterprise Data Center Infrastructure Management solutions, announces today the ... on feature enhancements in the area of capacity management and optimization, providing ...
(Date:4/28/2016)... , ... April 28, 2016 , ... One way to ... anything.” This is unfortunately true. But we toss the baby out with the bathwater ... brief provides tips for identifying higher-quality studies and otherwise making better use of education ...
(Date:4/28/2016)... , ... April 28, 2016 , ... USA Medical Card reminds us that May is ... a stroke is the fourth leading cause of death in the United States; someone has ... a quarter of them in individuals under 65 years old. A stroke is when ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... , April 27, 2016 ... ), a developer of a new generation of ... positive overall survival results for Paclical/Apealea in the ... 789 patients with epithelial ovarian cancer. These preliminary ... Paclical/Apealea in combination with carboplatin versus Taxol in ...
(Date:4/27/2016)... April 27, 2016 At the ... launch of a Phase 2 clinical study of its ... patients undergoing cochlear implantation (CI) surgery. This large, placebo-controlled, ... Germany and France ... ear at the time of surgery. "Despite advances in ...
(Date:4/26/2016)... CLEVELAND , April 26, 2016 ... is forecast to expand 4.9 percent annually to ... and other healthcare facilities to decrease rates of ... infection prevention supplies, equipment, and services.  Although declining, ... is significantly above targeted levels set by the ...
Breaking Medicine Technology: