Navigation Links
Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
Date:9/16/2009

PITTSBURGH, Sept. 16 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, 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 New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.

Mylan's product represents the first-ever fixed-dose combination of Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate and now provides Matrix with numerous Tenofovir combination product opportunities. This new drug adds to the Matrix portfolio of important treatments for HIV/AIDS. The product may be used for either first- or second-line treatment in adults. People use second-line therapies if and when they develop resistance to initially prescribed treatments.

Mylan President Heather Bresch said: "This product represents yet another important advance in our continuing fight against the global epidemic of HIV/AIDS. By combining three antiretroviral (ARV) products into a once-daily dose, we can dramatically improve the quality of care for people living with HIV/AIDS in emerging markets. Lower pill burden also increases the likelihood that patients adhere to treatment. This innovation also adds another affordable option to our large and rapidly growing portfolio of life-sustaining ARV products."

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 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 who are receiving treatment depend on Matrix ARV products.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates the world's third largest active pharmaceutical ingredient manufacturer; and runs 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. Scientific Journal Gene Therapy Reports That Cardiums Gene Activated Matrix Technology Accelerates Periodontal Tissue Regeneration
2. Matrixx Initiatives, Inc. Names William J. Hemelt President, CEO and Board Member
3. Matrixx Initiatives to Webcast 2009 Annual Stockholder Meeting Wednesday, August 26, 2009
4. Mylans Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla(R) HIV Treatment
5. Sigma-Aldrich Offers Customizable Synthetic Extracellular Matrix for Stem Cell Research
6. Matrixx Initiatives, Inc. Sets Time for Discussion of First Quarter Fiscal 2010 Financial Results
7. MedInsights Partners With myMatrixx(TM) for Workers Compensation Pharmacy Benefit Management
8. Matrixx Initiatives Confirms Voluntary Recall of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs
9. Matrixx Initiatives, Inc. Sets Time for Discussion of Recent FDA Action
10. Matrixx Initiatives Voluntarily Withdraws Zicam Cold Remedy Swabs, Zicam Cold Remedy Nasal Gel
11. Matrixx Initiatives, Inc. Received a Warning Letter From the Food and Drug Administration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/21/2017)... ... January 21, 2017 , ... ... Dianne Travis-Teague, the electrifying line-up of events for its annual meeting “Coming Home ... and community. “Coming Home 2017” will be held on Friday January 27 ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... Spectrum Aquatics Launches New ADA Portable Motion ... deck space. Since the lift is mounted on wheels, it can be wheeled out of ... down kit, to fasten to the deck. "We have transformed the feedback from customers into ...
(Date:1/20/2017)... ... January 20, 2017 , ... Bionic Sports Nutrition LLC, an American ... announced it had a successful January ECRM Trade Show in Hilton Head, SC. ... which allows it to provide its products to all clients at reasonable prices. At ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... "TransFlare 4K ... use inside of Final Cut Pro X," said Christina Austin - CEO of Pixel ... RED Dragon. Utilizing the Dragon Sensor,TransFlare 4K Mystique lens flare and light leak transitions ...
(Date:1/20/2017)... ... , ... “I Forgive You”: a fine examination of how God handles sin, including how ... published author, Stephen Miller, who, for over ten long years has been waiting to release ... Trinidad and Tobago, he has been serving the Lord for over twenty years, and he ...
Breaking Medicine News(10 mins):
(Date:1/20/2017)... DUBLIN , Jan 20, 2017 ... "Global Hearing Aids Market (by Devices, Implant Types, OTC Amplifiers, ... report to their offering. ... Global Hearing Aids Market Sales Volume, ... of the fast-evolving, high-growth hearing aid industry. The ...
(Date:1/20/2017)... Stock-Callers.com today evaluates the following Drug Manufacturers equities: ... A/S (NYSE: NVO ), Sucampo Pharmaceuticals Inc. (NASDAQ: ... PTX ). These stocks belong to the Healthcare ... finishing near its session lows. As per a NASDAQ report, ... of health care companies in the S&P 500 also were ...
(Date:1/20/2017)... 2017  Palladian Health, a leading provider of ... of an opioid management program which assists physicians ... helps stem the growing tide of dependence on ... chronic non-cancer pain (back pain, neck pain, and ... of evidence regarding long-term effectiveness. The ...
Breaking Medicine Technology: