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:12/9/2016)... 9, 2016  Forge Therapeutics, Inc. today announced ... Exchange: EVT, TecDAX, ISIN: DE0005664809) to advance its ... treatment of bacterial infections including those caused by ... an attractive antibacterial target for more than the ... chemical starting points has hampered its progress. Forge ...
(Date:12/8/2016)... Australia Ophthalmic Lasers Market Outlook to 2022 ... Market Outlook to 2022", provides key market data on ... in millions of US dollars, volume (in units) and ... Femtosecond Lasers and YAG Lasers. The report also ... of these market segements, and global corporate-level profiles of ...
(Date:12/8/2016)... Dec. 8, 2016 KEY FINDINGS ... Patient warming ... of blood during surgeries, lowering the risks of neurological disorders ... of SSIs. The patient warming systems can be segmented into ... benefits in turn reduce the stay at hospitals thus, lowering ...
Breaking Medicine Technology:
(Date:12/8/2016)... and JENNERSVILLE, Pa. (PRWEB) , ... December 08, ... ... that Penn Medicine Southern Chester County, a Property owned by an affiliate of ... million, 72,000 square foot Penn Medicine Southern Chester County ambulatory care center (ACC) ...
(Date:12/8/2016)... ... ... With the increasing demand for dental implants, the National Association of Dental ... dentists and patients about the safety issues related to dental restorations. According to the ... is projected to reach $6.4 billion in 2018 with more than 30 million Americans ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... for customers and employees that are both engaging and easy to use. Coming ... Technology, the software company revealed today its plans to roll out new AI-powered ...
(Date:12/8/2016)... ... December 08, 2016 , ... STATEN ISLAND, N.Y., Nov. 24, ... to the highest standards of trauma, maternity, cancer and chronic obstructive pulmonary disease ... CEO, Dr. Daniel Messina. , Among the recognitions, the American College of Surgeons' ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... as possible. With this in mind, SIGVARIS has created a new line of ... during bed rest and provide the benefits of graduated compression when transitioning from ...
Breaking Medicine News(10 mins):