Navigation Links
Mylan's Matrix Receives First Tentative FDA Approval Under PEPFAR for Generic Truvada(R)

PITTSBURGH, March 30 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first 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 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg.

Mylan Vice Chairman and CEO Robert J. Coury said: "This product approval is yet another important step in providing access to a range of critical HIV medications to patients in developing countries. Mylan and Matrix continue to make a significant contribution to bringing down the cost of these vital treatments through the expansion of our high-quality anti-retroviral franchise."

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are the generic version of Gilead Sciences Inc.'s Truvada(R) Tablets. Truvada(R) is a second-line anti-HIV drug in the nucleoside reverse transcriptase inhibitor (NRTI or "nuke") family and is used in combination with other medications to control HIV infection. Patients often use second-line therapies if and when they develop resistance to initially prescribed treatments or experience clinical failures.

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 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 biology technology :

1. NeoMatrix Announces Additional Funding for Breakthrough Breast Cancer Screening Test
2. BioNanomatrix Announces Issuance of Key Nanofluidics Patent Enabling Single Molecule Whole Genome Analysis
3. BioNanomatrix Receives New NCI Grant to Support Development of Chip-Based Nanofluidics Systems for Cell Fractionation
4. BioNanomatrix and Complete Genomics Receive $8.8 Million NIST-ATP Award to Develop Sequencing Platform for $100 Genome
5. TEI Biosciences Launches SurgiMend(TM) Collagen Matrix for Soft Tissue Reconstruction
6. Collagen Matrix, Inc. Launches OssiMend(TM) Bone Graft Matrix for Orthopedic and Spine Applications
7. Biosensors Receives CE Mark Approval for Its BioMatrix(R) Drug-Eluting Coronary Stent System
8. CombiMatrix and Clarient Collaborate to Market, Sell Novel Genomics-Based Test for Chronic Lymphotic Leukemia (CLL)
9. Organogenesis, Inc. Announces Acquisition of NanoMatrix, Inc.
10. Engineers make first active matrix display using nanowires
11. BioNanomatrix Named Best Management Team at the 2008 Ben Franklin Emerging Business Awards
Post Your Comments:
(Date:11/24/2015)... Nov. 24, 2015  Clintrax Global, Inc., a worldwide provider of ... , today announced that the company has set a new quarterly ... quarter on quarter growth posted for Q3 of 2014 to Q3 ... Mexico , with the establishment of an ... --> United Kingdom and ...
(Date:11/24/2015)... PA (PRWEB) , ... November 24, 2015 , ... This ... entrepreneurs at competitive events in five states to develop and pitch their BIG ideas ... projects from each state are competing for votes to win the title of SAP's ...
(Date:11/24/2015)... SHPG ) announced today that Jeff ... 27 th Annual Healthcare Conference in New York ... a.m. EST (1:30 p.m. GMT). --> SHPG ) announced ... in the Piper Jaffray 27 th Annual Healthcare Conference in ... 1, 2015, at 8:30 a.m. EST (1:30 p.m. GMT). --> ...
(Date:11/24/2015)... 2015  Tikcro Technologies Ltd. (OTCQB: TIKRF) today announced that its Annual ... 11:00 a.m. Israel time, at the law offices ... Street, 36 th Floor, Tel Aviv, Israel . ... and Izhak Tamir to the Board of Directors; , ... , approval of an amendment to certain terms of options granted ...
Breaking Biology Technology:
(Date:11/10/2015)... 10, 2015  In this report, the ... of product, type, application, disease indication, and ... report are consumables, services, software. The type ... biomarkers, efficacy biomarkers, and validation biomarkers. The ... diagnostics development, drug discovery and development, personalized ...
(Date:11/9/2015)... DUBLIN , Nov. 09, 2015 /PRNewswire/ ... announced the addition of the "Global ... to their offering. --> ... "Global Law Enforcement Biometrics Market 2015-2019" ... Research and Markets ( ) ...
(Date:11/4/2015)... ALBANY, New York , November 4, 2015 /PRNewswire/ ... According to a new market report published by Transparency ... Size, Share, Growth, Trends and Forecast 2015 - 2022", ... value of US$ 30.3 bn by 2022. The market ... during the forecast period from 2015 to 2022. Rising ...
Breaking Biology News(10 mins):