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:10/5/2017)... ROSEMONT, Ill. , Oct. 5, 2017 /PRNewswire-USNewswire/ ... American Association of Oral and Maxillofacial Surgeons (AAOMS) ... than opioids – to be used as a ... post-surgical pain. ... relationship, the AAOMS White Paper "Opioid Prescribing: Acute ...
(Date:10/2/2017)... , Oct. 2, 2017 Diplomat Pharmacy, Inc. ... Day Software and Consulting, LLC , and named its ... Software, based in Tennessee , will ... Day expands EnvoyHealth,s service offerings for health care partners ... "In an interoperable world, ...
(Date:10/2/2017)... 2, 2017 The Rebound mobile app is poised ... reverse the tide of prescription drug addiction. The app empowers ... intake and stepping down their dosage in a safe, controlled ... December 2017; the first 100,000 people to sign up will ... http://www.rebound-solution.com/ ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... While it’s often important to take certain medications during the night, finding ... identified a solution. , She developed a prototype for MOTION LIGHT-UP PILL BOX to ... the need to turn on a light when taking medication during the night, allowing ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the ... a national organization of elder law and special needs planning attorneys. “Membership in ElderCounsel ... also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids ... sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited ... all ages; it is a non-competitive, non-timed event, which is all about having fun ...
(Date:10/13/2017)... ... ... On The Brink”: the Christian history of the United States and the loss of ... William Nowers. Captain Nowers and his wife, Millie, have six children, ten grandchildren, ... Navy. Following his career as a naval aviator and carrier pilot, he spent ...
(Date:10/12/2017)... ... 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one of ... innovative new design of the shoulder pad. The shoulder pad provides optimal support ... your pain while using cold therapy. By utilizing ice and water that is circulated ...
Breaking Medicine News(10 mins):