Navigation Links
Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for Lamivudine and Zidovudine Tablets, 30 mg/60 mg
Date:1/20/2011

PITTSBURGH, Jan. 20, 2011 /PRNewswire/ -- 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 Lamivudine and Zidovudine Tablets, 30 mg/60 mg. The NDA is based on the reference listed drug Combivir®, by ViiV Healthcare. This innovative pediatric fixed-dose combination (FDC) in tablet form was developed by Matrix for use in treating children with HIV/AIDS. This product will be eligible for purchase outside the U.S. in certain developing countries.

Mylan President Heather Bresch said: "The approval of Lamivudine and Zidovudine is particularly important because it makes available an innovative FDC treatment option for children who are living with HIV/AIDS in developing countries. The addition of this product to our ARV franchise is a critical next step in helping to extend and improve the quality of life of people living with HIV/AIDS and to continue to expand access to high quality, affordable ARVs."

Lamivudine and Zidovudine Tablets, a combination of two nucleoside analogue reverse transcriptase inhibitors, are used in combination with other medications to control HIV infection. The FDA's tentative approval under PEPFAR means that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.

Matrix's wide range of ARV products includes active pharmaceutical ingredients and 34 first- and second-line finished doses, eight of which are pediatric products. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries depend on a Matrix ARV product.

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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Matrixx Initiatives, Inc. and H.I.G. Capital Announce Early Termination of HSR Waiting Period
2. First Patient Enrolled in Multi-Center Clinical Trial of the CorMatrix® ECM® for Pericardial Closure to Reduce the Incidence of New Onset Postoperative Atrial Fibrillation
3. SRI International and PhenoMatriX Collaborate to Develop Platin-Based Chemotherapies
4. National University Hospital Singapore Operates on Asias 1st TRAM Flap Patient Using TIGR® Matrix Surgical Mesh, the Worlds 1st Long-Term Resorbable Mesh
5. Collagen Matrix, Inc. Expands Operations and Moves Corporate Headquarters to Oakland, New Jersey
6. Matrixx Initiatives, Inc. Sets Time for Discussion of Fiscal 2011 Second Quarter Financial Results
7. National University Hospital Singapore Receives DSRB Approval to Use TIGR® Matrix Surgical Mesh in a New Randomized Controlled TRAM Flap Study
8. CorMatrix Receives FDA IDE Approval to Begin Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM™ for Pericardial Closure
9. DynaMatrix™ to be Featured on Discovery Channel Segment Highlighting Innovative Products in Oral Health
10. Matrixx Initiatives, Inc. Sets Time for Discussion of Fiscal 2011 First Quarter Financial Results
11. Novus Scientific Announces the Sales Launch for TIGR™ Matrix Surgical Mesh - Worlds 1st Long-Term Resorbable Synthetic Mesh
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/2/2017)... Aug. 2, 2017 CaryRx, a next-generation full-service pharmacy, ... service for patients in the Washington D.C. ... pharmacy by providing delivery of medications through the convenience of ... delivery or delivered within one hour to any location in ... to bring this invaluable service to Washington D.C. ...
(Date:7/28/2017)... July 28, 2017 Hill-Rom Holdings, Inc. ("Hill-Rom") ... third quarter ended June 30, 2017, and updated its ... For the fiscal third quarter, Hill-Rom ... $0.68 per diluted share in the prior-year period. These ... $0.39 per diluted share primarily related to the non-cash ...
(Date:7/26/2017)... 2017  Radium Medical Aesthetics, a leading medical aesthetic clinic in ... by effectively addressing several skin conditions from the inside. ... and more fragile. The skin becomes more transparent due to the ... harmful UV rays from the sun contributes to aging skin, causing ... ...
Breaking Medicine Technology:
(Date:8/19/2017)... ... 19, 2017 , ... DMG Productions, producers of the award ... an upcoming episode, slated to air fourth quarter 2017. Check your local listings ... a company committed to supporting dentistry using the most technologically advanced restorative materials ...
(Date:8/19/2017)... (PRWEB) , ... August 19, 2017 , ... Curl Keeper® ... of NaturallyCurly.com® The Curl Leaders, Editors’ Choice 2017 Award for the second year in ... for hair stylists and curlies alike was voted Best Moisturizer for Type 2 Wavies ...
(Date:8/19/2017)... ... August 19, 2017 , ... “Congratulations! It's A Boy! God’s Gift: ... both their parents and God. “Congratulations! It's A Boy! God’s Gift: A Story of ... from Long Island, New York. , Published by Christian Faith Publishing, Dale Anthony and ...
(Date:8/18/2017)... NY (PRWEB) , ... August 18, 2017 , ... ... of “Vision & Hearing” campaign, advocating for active, healthy lifestyles and highlighting the ... available for individuals with hearing impairments and shares the latest innovations in hearing ...
(Date:8/18/2017)... VA (PRWEB) , ... August 18, 2017 , ... ... asset protection services and financial consultations to communities throughout the greater DC region, ... K9 with the goal of rescuing local animals and training them to be ...
Breaking Medicine News(10 mins):