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:1/17/2017)... Jan. 17, 2017 EU5 Glucose Monitoring Market ... report, "EU5 Glucose Monitoring Market Outlook to 2022", provides ... The report provides value, in millions of US dollars, ... segments - Blood Glucose Meters, Blood Glucose Test Strips ... and distribution shares data for each of these market ...
(Date:1/17/2017)... Jan. 17, 2017 Paragon Bioservices received a ... development services for a variety of National ... medical product development activities. The IDIQ mechanism will ... for task order awards up to $159 million. ... manufacturing and process development of biopharmaceuticals, is one ...
(Date:1/17/2017)... 2017  Pennsylvania Secretary of Health Dr. ... marijuana growers/processors and dispensaries are now available on ... Permit applications will be accepted from February 20 ... an important step forward in getting this valuable ... Murphy said. "We,ve developed a thorough application that ...
Breaking Medicine Technology:
(Date:1/17/2017)... Lehi, Utah (PRWEB) , ... January 17, 2017 ... ... provider of accredited, online continuing education for EMS and firefighting professionals, has released ... Training (VILT) Solution. These new courses are taught live in an online classroom ...
(Date:1/17/2017)... TEXAS (PRWEB) , ... January 17, 2017 , ... ... provider, today announced its partnership with Sigfox in the U.S.A. to ... cities nationwide including new offerings on large-scale environmental sensor deployments such as ...
(Date:1/17/2017)... ... January 17, 2017 , ... Livionex, Inc., a Silicon Valley healthcare company focused ... study for its dental gel that shows significant reduction in plaque levels and gum ... The study was conducted at the Beckman Laser Institute at UC Irvine and has ...
(Date:1/17/2017)... , ... January 17, 2017 , ... ... private companies and ranked among the top US security companies for consecutive years, ... This announcement brings a year-long independent board nomination process to a close ...
(Date:1/16/2017)... ... January 17, 2017 , ... ... an internationally recognized leader in the fast-casual category, announces a hearty and wholesome ... Good Egg Breakfast Sandwich, Turkey Mash-Up Sandwich, Cranberry Crunch & Honey Parfait, Slow ...
Breaking Medicine News(10 mins):