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

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

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:
(Date:11/25/2015)... Nov. 25, 2015 AAIPharma Services Corp./Cambridge ... of at least $15.8  Million to expand its ... NC . The expansion will provide additional ... the growing demands of the pharmaceutical and biotechnology ... expansion will provide up to 40,000 square feet ...
(Date:11/25/2015)... -- ARKRAY USA , Inc., a leader ... the accuracy of its blood glucose meter systems. Last ... and Cardiovascular Disease in Los Angeles ... 01 meter and the Assure ® Prism ... accurately measure glucose levels in blood is essential for ...
(Date:11/25/2015)... 2015 Kitov Pharma ceuticals ... a biopharmaceutical company focused on the development of therapeutic ... today announced the closing of its previously announced underwritten ... ), each representing 20 ordinary shares of the Company, ... ADSs and warrants were issued in a fixed combination ...
Breaking Medicine Technology:
(Date:11/27/2015)... Aliso Viejo, CA (PRWEB) , ... November 27, 2015 , ... ... exclusively for use in Final Cut Pro X. With ProSidebar: Fasion, video editors ... banners, or use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating ...
(Date:11/27/2015)... ... 2015 , ... Intellitec Solutions announced today that they have ... as Microsoft’s official group for end users of Dynamics SL ERP software, the ... experts and representatives. Intellitec Solutions’ membership status demonstrates their ongoing commitment to the ...
(Date:11/27/2015)... Bangalore, Karnataka (PRWEB) , ... November 27, 2015 ... ... the world, Health-E-minds, an innovative online platform for mental health and wellness consultation, ... KleverKid. , This partnership will bridge the knowledge gap experienced by parents and ...
(Date:11/27/2015)... , ... November 27, 2015 , ... Dr. Thomas ... Associates, Inc. and Dr. Tucker Bierbaum with Emergency Medicine at St., Joseph ... that both STEMI and Sepsis conditions present in similar ways and require time-critical intervention ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients ... central Michigan, have come together on Thanksgiving Day to share the things that ... viewing on the Serenity Point YouTube channel, patients displayed what they wrote on ...
Breaking Medicine News(10 mins):