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 AR
'/>"/>

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

Page: 1 2

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:7/14/2014)... (PRWEB) July 14, 2014 The ... increasing demand for clean energy, initiatives of associations ... the major factors which drive the growth of ... metals are used in various direct applications ranging ... and x-rays, among others. , North America is ...
(Date:7/14/2014)... 14, 2014)In the 2,500+ years that have passed ... Chinese, it has been used to treat a ... nausea and vomiting, stroke rehabilitation, headaches, menstrual cramps, ... just a few. Now, a meta-analysis of ... month in Menopause , the journal of ...
(Date:7/14/2014)... There’s an old adage that says first ... Palette say the products offered in their preorder event ... can reserve The Lash Palette for $40,” said Jenelle Paris, ... , Paris explained that the first 1,000 have already been ... She went on to point out that her company is ...
(Date:7/14/2014)... The governments in many countries are developing health ... Solutions market. For instance, in the US, Barack Obama's ... Clinical Health Act under the American Recovery and Reinvestment ... Global Mobile Health Solutions market will grow at ... According to the report, one of the prime drivers ...
(Date:7/14/2014)... has entered into an agreement with one of ... novel drug candidates for the detection and treatment ... in novel antibody discovery and Roche,s expertise in ... the possibility of improved treatment for cancer, a ... collaboration makes use of BTI,s discovery of a ...
Breaking Medicine News(10 mins):Health News:North America Rare Earth Metals Market is Expected to Grow at a CAGR of 8% - New Report by MicroMarket Monitor 2Health News:North America Rare Earth Metals Market is Expected to Grow at a CAGR of 8% - New Report by MicroMarket Monitor 3Health News:North America Rare Earth Metals Market is Expected to Grow at a CAGR of 8% - New Report by MicroMarket Monitor 4Health News:Bothered by hot flashes? Acupuncture might be the answer 2Health News:The Lash Palette Preorder Event Has Officially Begun 2Health News:Mobile Health Solutions Market to Grow at 34.88% CAGR by 2018, Says a New Research Report at Sandlerresearch.org 2Health News:Mobile Health Solutions Market to Grow at 34.88% CAGR by 2018, Says a New Research Report at Sandlerresearch.org 3Health News:Mobile Health Solutions Market to Grow at 34.88% CAGR by 2018, Says a New Research Report at Sandlerresearch.org 4Health News:A*STAR partners Roche to develop new cancer therapeutics 2
... Aug. 7 /Xinhua-PRNewswire-FirstCall/ -- Aamaxan,Transport Group, Inc. ... AAXT),through its subsidiaries, including Shanghai Medical Technology ... a leading provider of Hemodialysis,equipment ("HDE") and ... diagnostic products, throughout Eastern China, today,announced the ...
... (Nasdaq:,MITI), a biopharmaceutical company focusing on the development ... inflammation and,autoimmune diseases, today announced its financial results ... 30, 2008., Summary of Recent Events:, ... update for the,BiTE(R) antibody blinatumomab (MT103/MEDI-538) at the ...
... - Annual revenue increases 5 percent to ... 76 percent to $3.64 and 11 percent to ... $23 billion, GAAP diluted, earnings per share from continuing operations increase 51 percent ... and 9 percent to $0.97 on a non-GAAP basis ...
... Calif., Aug. 7 The Board of Directors,of Endocare, ... 2008 an unsolicited,proposal from HealthTronics, Inc. (Nasdaq: HTRN ... common stock for $2.28 per share in cash., ... in consultation with its financial and legal advisors, will ...
... Consulting, a division of Gallagher Benefit Services, Inc., today announced the ... which examines current employee benefit trends and strategies. , ... ... division of Gallagher Benefit Services, Inc., today announced the release of ...
... Advice on Lap-Band Gastric Banding Procedure--Hundreds of Thousands with 30 ... Loss and to Ease Weight-Related Symptoms Including Diabetes, High Blood ... and Sleep Apnea. , ... Dallas ...
Cached Medicine News:Health News:Shanghai Medical Technology Co., Appoints Chief Financial Officer 2Health News:Shanghai Medical Technology Co., Appoints Chief Financial Officer 3Health News:Micromet, Inc. Reports Second Quarter 2008 Financial Results 2Health News:Micromet, Inc. Reports Second Quarter 2008 Financial Results 3Health News:Micromet, Inc. Reports Second Quarter 2008 Financial Results 4Health News:Micromet, Inc. Reports Second Quarter 2008 Financial Results 5Health News:Micromet, Inc. Reports Second Quarter 2008 Financial Results 6Health News:Micromet, Inc. Reports Second Quarter 2008 Financial Results 7Health News:Micromet, Inc. Reports Second Quarter 2008 Financial Results 8Health News:Micromet, Inc. Reports Second Quarter 2008 Financial Results 9Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 2Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 3Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 4Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 5Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 6Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 7Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 8Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 9Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 10Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 11Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 12Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 13Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 14Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 15Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 16Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 17Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 18Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 19Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 20Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 21Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 22Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 23Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 24Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 25Health News:Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook 26
(Date:7/14/2014)... , 14 de julio de 2014 /PRNewswire-HISPANIC PR ... anunciar que Barry Epling , presidente de la ... CEO de la Compañía. El señor Epling es el ... que otorgó la licencia de su formulación, sus propiedades ... proveedor de apoyo financiero. "El señor ...
(Date:7/14/2014)... , July 14, 2014  Invivotek L.L.C., a ... pleased to announce that its animal research facility ... the Assessment and Accreditation of Laboratory Animal Care ... animals in science worldwide through voluntary accreditation and ... animal care and use in 38 countries. ...
(Date:7/14/2014)... July 14, 2014 Valeant Pharmaceuticals International, ... VRX) today announced it has filed a premerger ... 1976 (HSR) with the U.S. Federal Trade Commission ... Inc. (NYSE: AGN). About Valeant ... International, Inc. (NYSE/TSX: VRX) is a multinational specialty ...
Breaking Medicine Technology:BioAdaptives se prepara para el próximo paso 2BioAdaptives se prepara para el próximo paso 3Invivotek Awarded Full AAALAC Accreditation for Excellence in Laboratory Animal Care and Use 2Valeant Pharmaceuticals Submits HSR Filing Relating To Proposed Acquisition Of Allergan 2Valeant Pharmaceuticals Submits HSR Filing Relating To Proposed Acquisition Of Allergan 3Valeant Pharmaceuticals Submits HSR Filing Relating To Proposed Acquisition Of Allergan 4Valeant Pharmaceuticals Submits HSR Filing Relating To Proposed Acquisition Of Allergan 5
... PCI program is critical, CHICAGO, March 29 ... and successfully in medical centers without,on-site cardiac surgical ... to quality. These are the findings of the,largest ... have on-site,cardiac surgery to PCI programs that transfer ...
... days and out to 450 days in patients who ... either bare metal or drug-eluting stents, CHICAGO, March 29 ... and highly,statistically significant reduction in the risk of coronary stent,thrombosis ... fatal consequences - in patients who received a stent as,compared ...
Cached Medicine Technology:Study Finds PCI Safe, Effective Despite Off-Site Cardiac Surgery 2Study Finds PCI Safe, Effective Despite Off-Site Cardiac Surgery 3Study Finds PCI Safe, Effective Despite Off-Site Cardiac Surgery 4Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel 2Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel 3Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel 4Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel 5Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel 6Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel 7
The ACMI™ line of laparoscopic hand instruments is designed to provide a wide selection of popular surgical devices to meet procedural needs....
The Snap-In Snap-Out-II Tip Inserts offer a large variety of configurations....
The Snap-In Snap-Out-II Tip Inserts offer a large variety of configurations....
The Optima III line of laparoscopic hand instruments provides a well-crafted set of instruments designed for strength and durability....
Medicine Products: