Navigation Links
Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories' New Drug Application (NDA) for Efavirenz Tablets

PITTSBURGH, Dec. 22 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that its 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 Tablets, 50 mg, 100 mg and 200 mg. These innovative pediatric dosages in tablet form were developed by Matrix for use in treating pediatric HIV/AIDS.

Mylan President Heather Bresch commented: "This New Drug Application represents another successful innovation by Matrix in the fight against HIV/AIDS. Our HIV/AIDS antiretroviral (ARV) franchise continues to grow and to bring more affordable, high quality medications to patients in the developing world. We are extremely pleased to be able to add these new dosages to the basket of treatment options currently available to the medical community, and to expand our portfolio of products for treating pediatric HIV/AIDS."

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (nNRTI) that has been found to be effective in many combination regimens for the treatment of HIV infection, both in treatment-naive and in treatment-experienced individuals.

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 person of effective therapies. Approximately 30% of people living with HIV/AIDS 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 one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit

SOURCE Mylan Inc.

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

Related medicine technology :

1. Mylan Added to NASDAQ-100 Index
2. Mylan Receives Approval for Generic Version of Antiepileptic Keppra(R) 1000 mg
3. Mylan Announces Settlement Agreement Related to Antidepressant Effexor XR(R)
4. Mylans President of Europe, Middle East and Africa Elected President of European Generic Medicines Association
5. Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
6. Mylan Schedules Third Quarter 2009 Financial Results Conference Call and Live Webcast
7. Mylan Receives FDA Approval for Generic Version of Parkinsons Treatment Sinemet(R)
8. The Make-A-Wish Foundation(R) Receives $1 Million Donation from LATISSE(R) Wishes Campaign
9. BASFs Aseptrol(R) S10 - Tab Receives EPA Approval For H1N1 Sanitization Label
10. CareCentrix Receives URAC Health Utilization Management Accreditation
11. Savara Closes Second Tranche of Series A Financing Round, Receives Allowance for Base Patent
Post Your Comments:
(Date:6/23/2016)... Calif. , June 23, 2016 ... CST on Thursday, July 7, 2016 , , , , ... ) , , , , EXPERT PANELISTS:  , , ... Naik; Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar ... The global pharmaceutical industry is witnessing an exceptional ...
(Date:6/23/2016)... 2016 Revolutionary technology includes multi-speaker ... , industry leaders in advanced audiology and hearing aid ... Opn ™, the world,s first internet connected hearing aid ... devices.      (Photo: ) ... of ,world firsts,: , TwinLink™ - the ...
(Date:6/23/2016)... June 23, 2016 Research and ... Procedure Volumes: Global Analysis (United States, China, Japan, Brazil, ... report to their offering. ... for healthcare business planners, provides surgical procedure volume data ... trends with an in-depth analysis of growth drivers and ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... Fla. (PRWEB) , ... June 24, 2016 , ... Global ... Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition ... Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this year’s ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
Breaking Medicine News(10 mins):