Navigation Links
Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories' New Drug Application (NDA) for Efavirenz Tablets
Date:12/22/2009

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 www.mylan.com.

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:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... Visiomed, the French leader in medical ... changing the landscape of healthcare with their innovative ... custom-made solutions. Recognizing the rising demand of self-monitoring ... without walls, Visiomed has launched BewellConnect, the most ... professionals that is empowering the lives of patients. ...
(Date:2/23/2017)... -- ITL Limited, ( ASX: ITD ), an innovative diversified healthcare ... ended 31 December 2016 compared with the previous corresponding period. A ... here . Highlights ... Earnings per share of 2.2 cents (Dec 2015: 1.2 ... $15.7m; up 11%) Profit before tax of $2.12m ...
(Date:2/23/2017)... , Feb. 23, 2017 Research and ... Analysis and Strategies - 2016" report to their offering. ... The latest research ... data and benchmarks in the global Fibromyalgia market. The ... the key drugs marketed for Fibromyalgia and their clinical attributes? How ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... An in-depth computational analysis ... University of Pittsburgh points to eight genes that may explain why susceptibility to one ... the results of a study published today in the journal npj Schizophrenia. , ...
(Date:2/24/2017)... (PRWEB) , ... February 24, 2017 , ... Healthcare ... The Medical Center at Craig Ranch building at 8080 State Highway 121, Suite 210, ... District with easy access to Highway 121. , As the practice has grown, the ...
(Date:2/24/2017)... ... February 24, 2017 , ... The International Association of Eating Disorders Professionals (iaedp) ... You See” body image mannequin art competition. Selected from 15 submissions from around the ... revealed at the 31st annual iaedp Symposium, March 22 – 26 in Las Vegas. ...
(Date:2/24/2017)... ... February 24, 2017 , ... ... once again hosted their Military Wedding Giveaway, with the winning couple announced on ... Farms with services generously donated from local vendors: A Matter of Taste, Ryan ...
(Date:2/23/2017)... , ... February 23, 2017 , ... ... with a clinician-based audience, will be participating in Rare Disease Day events, hosted ... D.C. In addition, Rare Disease Report, a website, weekly e-newsletter and quarterly publication, ...
Breaking Medicine News(10 mins):