Navigation Links
Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for First Generic, Heat-Stable Version of HIV Protease Inhibitor

Provides first affordable protease inhibitor for patients in developing countries Complements recent WHO approval earned for the same product

PITTSBURGH, March 12 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, has received the first and only 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 Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.

Mylan Vice Chairman and CEO Robert J. Coury said: "Mylan and Matrix are committed to our growing and high quality antiretroviral franchise. Our goal is to provide HIV treatments to patients around the world -- especially in developing countries. With Matrix's heat-stable and affordable version of Lopinavir/Ritonavir, patients in remote parts of developing nations will have access to this important life-saving drug. This is the second regulatory approval that this important product has recently earned, which further confirms our commitment to providing high-quality medicines at affordable prices."

Lopinavir/Ritonavir Tablets are the generic version of Abbott Laboratories' Kaletra(R) Tablets, the brand marketed in the U.S. and Europe, and Aluvia(R) Tablets, the brand marketed in developing countries. It is used in combination with other medications to control HIV infection and is included in the antiretroviral (ARV) class of drugs known as HIV protease inhibitors.

Last month, Matrix was awarded the first and only World Health Organization (WHO) approval for the same product. These approvals indicate that Matrix's Lopinavir/Ritonavir tablets meet international safety, efficacy and manufacturing quality standards. This status will significantly increase access to affordable, high quality medicines in many countries, particularly priority countries with high AIDS prevalence rates.

Matrix's wide range of ARV products includes active pharmaceutical ingredients (API) and first- and second-line finished doses. Patients often use second-line therapies if and when they develop resistance to initially prescribed treatments or experience clinical failures. 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 Matrix ARV products.

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

SOURCE Mylan Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. CorMatrix Cardiovascular Announces First European Implants of CorMatrix(R) ECM Technology(TM)
2. Mylans Matrix Receives WHO Approval for First Generic, Heat-Stable Version of HIV Protease Inhibitor
3. Matrixx Initiatives, Inc. to Present at the Roth Capital Partners 21st Annual OC Growth Stock Conference
4. Matrixx Initiatives, Inc. Reports Third-Quarter Net Sales Increased 26% to $38.7 Million, Net Income Increased to $4.8 Million, or $0.50 Earnings Per Share
5. Matrixx Initiatives, Inc. Sets Time for Discussion of Third Quarter Fiscal 2009 Financial Results
6. Matrixx Initiatives Selects GolinHarris as Agency of Record for Zicam Brand
7. Mylans Matrix Receives Final FDA Approval for the Generic Version of the Antiretroviral Zerit(R) Capsules
8. BioNanomatrix Appoints Gary Zweiger, Ph.D., as Vice President of Business Development
9. Mylans Matrix First-to-File on Generic Version of Vfend(R) Antifungal
10. Photos: For the First Time Researchers Show Reversal of an Aging Marker in the Human Retina Correlated with Visual Improvement Using a Nutraceutical Matrix (Longevinex(R))
11. Matrixx Initiatives, Inc. Announces Fiscal 2008 Revenue of $101 Million and Net Income Growth of 59% to $10.4 Million, or $1.04 Earnings Per Share Versus $0.66 in the Prior Year
Post Your Comments:
(Date:11/24/2015)... ... November 24, 2015 , ... The ... comes to several aspects of orthopedic care. They have received recognition for excellence ... general orthopedic care. , Becker's Hospital Review selected hospitals for inclusion based ...
(Date:11/24/2015)... Salt Lake City, UT (PRWEB) , ... November 24, 2015 , ... ... according to Forbes Magazine. For a business, it is critical that the first impression ... of a business, they are not likely to buy anything or want to return. ...
(Date:11/24/2015)... ... November 24, 2015 , ... Brillouin Energy ... Brillouin is the developer of renewable energy technologies capable of producing commercially useful ... announced today that its WET™ and HHT™ Boiler System reactor core modules were ...
(Date:11/24/2015)... ... November 24, 2015 , ... United Benefit ... welcome Winter-Dent & Company as its newest Partner Firm. Based in Jefferson City, ... client's most trusted advisor regardless of whether that client is a business, a ...
(Date:11/24/2015)... ALEXANDRIA, VA (PRWEB) , ... November 24, 2015 ... ... encourages people across the United States to support their local poison centers through ... been designated as #GivingTuesday: calls it “a day that inspires people to ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... --  HeartWare International, Inc . (NASDAQ: HTWR ), ... that are revolutionizing the treatment of advanced heart failure, ... Doug Godshall is scheduled to present at the ... December 1, 2015 at 3:00 p.m. ET.  The conference ... York . .  A ...
(Date:11/24/2015)... F1000Workspace - a research collaboration, reference management ... just six months ago. --> F1000Workspace - ... - since it was launched just six months ago. ... F1000Workspace - a research collaboration, reference management and ... six months ago. --> --> ...
(Date:11/24/2015)... , Nov. 24, 2015 iRhythm Technologies, Inc. ... cardiac care, today announced that it will participate in the 27th ... in New York, NY . Kevin ... on Tuesday December 1, 2015 at 8:50am ET. ... . --> . --> ...
Breaking Medicine Technology: