Navigation Links
Mylan's Matrix Receives First Tentative FDA Approval Under PEPFAR for Generic Truvada(R)
Date:3/30/2009

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 www.mylan.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 A person commits ... the crime scene to track the criminal down. ... U.S. Food and Drug Administration (FDA) uses DNA evidence to ... Sound far-fetched? It,s not. The FDA has ... to support investigations of foodborne illnesses. Put as simply as ...
(Date:6/23/2016)... Cancer Foundation (PCF) is pleased to announce 24 new Young Investigator (YI) ... of the Class of 2016 were selected from a pool of 128 applicants ... the Class of 2016 PCF Young Investigators ... ... ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry ... Supplyframe Design Lab . Located in Pasadena, Calif., the Design Lab’s mission ... hardware projects are designed, built and brought to market. , The Design Lab ...
(Date:6/23/2016)... Ky. , June 23, 2016 ... two Phase 1 clinical trials of its complement ... placebo-controlled, single and multiple ascending dose studies designed ... pharmacodynamics (PD) of subcutaneous injection in healthy adult ... subcutaneously (SC) either as a single dose (ranging ...
Breaking Biology Technology:
(Date:6/15/2016)... 15, 2016 Transparency Market ... Recognition Market by Application Market - Global Industry Analysis Size ... to the report, the  global gesture recognition market ... and is estimated to grow at a CAGR ... 2024.  Increasing application of gesture recognition ...
(Date:6/3/2016)... LONDON , June 3, 2016 /PRNewswire/ ... Transport Management) von Nepal ... ,Angebot und Lieferung hochsicherer geprägter Kennzeichen, einschließlich ... weltweit führend in der Produktion und Implementierung ... an der Ausschreibung im Januar teilgenommen, aber ...
(Date:6/1/2016)... , June 1, 2016 Favorable ... Election Administration and Criminal Identification to Boost Global Biometrics ... recently released TechSci Research report, " Global Biometrics Market ... Competition Forecast and Opportunities, 2011 - 2021", the global ... by 2021, on account of growing security concerns across ...
Breaking Biology News(10 mins):