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

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 For more information about generic drugs, please visit

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:
(Date:11/26/2015)... 26, 2015 ... "Radioimmunoassay Market by Type (Reagents & ... Academics, Clinical Diagnostic Labs), Application (Research, Clinical ... 2020" report to their offering. ... addition of the "Radioimmunoassay Market by ...
(Date:11/25/2015)... , Nov. 25, 2015  The American Academy ... Gynecologists (ACOG), and the March of Dimes cheered ... Protecting Our Infants Act of 2015 (S.799), ... of newborns born exposed to drugs, such as ... bill,s introduction, all three organizations have worked together ...
(Date:11/25/2015)... 25, 2015  Henry Schein, Inc., the world,s largest ... dental, medical and animal health practitioners, will unveil at ... Henry Schein ConnectDental® Pavilion , which brings together for ... solutions designed to help any practice or laboratory enter ... for a schedule of experts appearing at the Pavilion. ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television series, "Voices in ... that delves into an array of issues that are presently affecting Americans. Dedicated to ... dialogue, this show is changing the subjects consumers focus on, one episode at a ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... and prominent nonprofit healthcare organizations in the country. They have overseen financial turnarounds, ... and helped advance the healthcare industry as a whole through their advocacy and ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at Serenity Point Recovery, ... together on Thanksgiving Day to share the things that they are most grateful ... Point YouTube channel, patients displayed what they wrote on index cards, describing the ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... ... of workshops to discuss bioavailability and the need to integrate dose form selection ... in collaboration with OBN, the membership organization supporting and bringing together the UK’s ...
(Date:11/26/2015)... Viejo, CA (PRWEB) , ... November 26, 2015 ... ... users a new set of retro-fused, self-animating trailer titles with ProTrailer: Vintage. This ... style options. These classically-influenced trailer titles work with any font, giving users limitless ...
Breaking Medicine News(10 mins):