Navigation Links
Mylan Receives Tentative FDA Approval Through PEPFAR for First Heat-Stable, Fixed-Dose Combination of Atazanavir Sulfate and Ritonavir Tablets for HIV/AIDS
Date:12/1/2011

PITTSBURGH, Dec. 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the U.S. Food and Drug Administration (FDA) through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Atazanavir Sulfate and Ritonavir Tablets, 300 mg/100 mg.

This product is the first heat-stable, fixed-dose combination of Atazanavir Sulfate and Ritonavir, an antiretroviral (ARV) used to treat HIV/AIDS. It also has been "prequalified" by the World Health Organization (WHO) as a second-line treatment option and can be used in combination with other ARVs for the treatment of HIV/AIDS. It will be eligible for purchase outside the U.S. in certain developing countries; it also will be a significant addition to Mylan's ARV portfolio in India, which is expected to become available during the second quarter of 2012.

Mylan President Heather Bresch said: "The approval of this fixed dose product is a groundbreaking development for the treatment of second-line HIV/AIDS patients. For the first time, it makes available a generic antiretroviral (ARV) drug with Atazanavir Sulfate and Ritonavir in a fixed-dose combination tablet. This 'combo' helps to facilitate treatment compliance for HIV/AIDS patients by providing a convenient, once-a-day dosing option, while reducing the cost of treatment for patients. The approval is representative of Mylan's continued commitment to providing critical life-saving therapies to people living with HIV/AIDS around the world."

The FDA's tentative approval through PEPFAR signifies that Mylan's product meets all of the agency's manufacturing quality, safety and efficacy standards. Atazanavir and Ritonavir are the generic versions of Bristol-Myers Squibb's Reyataz® and Abbott Laboratories' Norvir®, respectively.

Mylan's wide range of ARV products includes active pharmaceutical ingredients and 39 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 one-third of HIV/AIDS patients in developing countries depend on a Mylan ARV product.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 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 about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Launches Generic Version of Caduet® Tablets
2. Mylan Confirms First-to-File Patent Challenge Relating to Generess™ Fe
3. Mylan Committed to Expanding Access in Developing Countries to High Quality, Affordable HIV/AIDS Treatment
4. Mylan Receives Approval for Generic Version of Zinecard® for Injection
5. Mylan Announces Settlement Agreement for its First-to-File Generic Version of Vivelle-Dot®
6. Mylan Successfully Upsizes and Completes Refinancing of Credit Facility
7. Mylan Applauds Obama Administrations Call to Create an "AIDS-Free Generation" Through Global Fight Against HIV/AIDS
8. Mylan to Acquire Pfizer Respiratory Delivery Platform
9. Mylan Receives Approval for Generic Version of MS Contin® Tablets
10. Mylan Launches First Generic Version of Exelon® Capsules in the U.K.
11. Mylans Dey Pharma Successfully Obtains Patent Reexamination Certificates for Two Perforomist® Patents
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/13/2017)... OrthoAtlanta has been named the official orthopedic and sports ... the 2018 College Football Playoff (CFP) National Championship to be ... Atlanta, Georgia . OrthoAtlanta is proud to ... in many activities leading up to, and including the national ... OrthoAtlanta ...
(Date:9/12/2017)...  Consumer reviews on the independent review site Consumer Affairs ... company for hearing aids, ranking it higher than Miracle Ear ... ... For Hearing Aids ... online store that provides high performance, state-of-the-art, German-engineered hearing aids directly ...
(Date:9/9/2017)... ... ... – Monday, September 18 th .The Brain Tumor Foundation (BTF) begins ... the public.Where:  BTF,s Mobile MRI Unit – a ... Washington, D.C.What:BTF brings its nationwide initiative, the Road to Early Detection Sponsor-A-City ...
Breaking Medicine Technology:
(Date:10/13/2017)... , ... October 13, 2017 , ... PurhealthRX , ... Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize ... providing a CBD form that can be easily incorporated into liquid products, while reducing ...
(Date:10/13/2017)... RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... annual Holly Day Market. Featuring a collection of specialty vendors and unique items from ... of personalized and quality-focused health and wellness services offered by the VNA. The ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... DevOps and Agile Software Development, has been awarded a contract by the Center ... Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
Breaking Medicine News(10 mins):