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:1/16/2017)... ... January 16, 2017 , ... Board-certified oculoplastic surgeon Dr. ... the official journal of The American Society for Aesthetic Plastic Surgery, in which ... is designed to correct drooping, retracted lower eyelids, which usually result from genetics, ...
(Date:1/16/2017)... ... ... NexTec Group has been selected as a member of the Bob Scott’s VAR ... field of midmarket financial software. , Members of the VAR Stars were selected based ... on revenue and those firms chosen represent a wide range of size and many ...
(Date:1/15/2017)... California (PRWEB) , ... January 15, 2017 , ... "On ... stylistic slideshow with complete customization and ease," said Christina Austin - CEO of Pixel ... controls so that users can edit the style and animation of their slideshows. Place ...
(Date:1/14/2017)... (PRWEB) , ... January 14, 2017 , ... ... the distinctions among their expanding line of activated charcoal products. With more and ... importance of categorizing their products according to how they cater to specific needs. ...
(Date:1/13/2017)... ... 13, 2017 , ... The 18th European Congress: Perspectives in Lung Cancer will ... This Congress is expertly designed to meet the educational needs of European oncology ... , Chaired by Dr. Giorgio V. Scagliotti, Professor of Oncology at the University of ...
Breaking Medicine News(10 mins):
(Date:1/13/2017)... 2017 On Thursday, January 12, ... and the S&P 500 edged lower at the closing ... session in bearish territories. Taking into consideration yesterday,s market ... morning: Myriad Genetics Inc. (NASDAQ: MYGN ), ... Holdings Inc. (NASDAQ: INCR ), and La ...
(Date:1/13/2017)...  Secretary of Health Karen Murphy today ... at Misericordia University and discussed the Wolf Administration,s efforts ... . "The opioid epidemic is the ... my professional career," Secretary Murphy said. "This area of ... by heroin and prescription opioid overdoses. Across the commonwealth ...
(Date:1/13/2017)... , Jan. 13, 2017 Concord Medical Services ... CCM ), a leading specialty hospital management solution ... and diagnostic imaging centers in China ... fund with Zhongrong International Trust Co., Ltd. ("ZRT"). ... to set up Zhongrong Taihe Healthcare Fund in October ...
Breaking Medicine Technology: