Mylan receives tentative FDA approval for paediatric formulations of abacavir/lamivudine through innovative collaboration with ViiV Healthcare and Clinton Health Access Initiative - Seite 2

Dr. Dominique Limet, CEO ViiV Healthcare commented on the news, "Based on the need clearly identified by the Clinton Health Access Initiative in 2012, ViiV Healthcare became the first pharmaceutical company to fully fund the entire development process for a paediatric formulation of an HIV medicine which would then be transferred to another company for manufacture and distribution in the developing world.  I congratulate Mylan on this approval, made even more meaningful for us at ViiV Healthcare as it proved that this innovative approach to partnership can work." 

David Ripin, Executive Vice President and Chief Scientific Officer for CHAI said, "We are pleased that our partnership with ViiV and Mylan has resulted in an important new paediatric formulation, moving from concept to FDA tentative approval in less than two years.  The new, flavoured dispersible medication will help meet the needs of over 500,000 children being treated for HIV in low middle income countries and demonstrates leadership and innovation on the part of both originators and generic suppliers together to address the needs of paediatric patients worldwide.  We are pleased to have participated in this innovative public-private partnership with the support of the UK Department for International Development."

About abacavir/lamivudine
Abacavir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs interfere with the action of the reverse transcriptase enzyme to prevent the virus from replicating.

Abacavir/lamivudine was approved in the US in August 2004 under the brand name Epzicom and in Europe in December 2004 under the brand name Kivexa.

Kivexa and Epzicom are registered trademarks of the ViiV Healthcare group of companies.

About President's Emergency Plan for AIDS Relief (PEPFAR)
PEPFAR is the U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world. This historic commitment is the largest by any nation to combat a single disease internationally. In May 2004, in support of the President's Emergency Plan, FDA announced a new initiative to help ensure that those being served by the Presidents' Plan would receive safe, effective, and quality manufactured antiretroviral drugs. This new initiative included an expedited review process. Through guidance and an active outreach program to the pharmaceutical industry, FDA actively encouraged any sponsors worldwide to submit U.S. marketing applications for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies - even if there was still patent or exclusivity market protection for the product in the U.S.