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US FDA approves Mylan’s NDA’s for two dosages of abacavir/lamivudine tablets

Mylan Laboratories has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.

This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavored. The FDA’s tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR) program means the formulations meet all of the agency’s quality, safety and efficacy standards.

The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative (CHAI) and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation, at low cost, to a total of 115 resource limited countries including all low-middle income, least developed countries and sub-Saharan Africa. Mylan’s products are expected to be eligible for purchase in early 2015.

The fixed dose combination of abacavir and lamivudine tablets for oral suspension 60 mg/30 mg and 120 mg/60 mg is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents for pediatric patients.

More than 70% of the approximately 3.4 million children living with HIV worldwide do not have access to appropriate care and medicines1. Improving those numbers will require medicines that are palatable to children and affordable to those living in resource-limited settings.

"The approval of abacavir and lamivudine tablets for oral suspension for marketing in developing markets demonstrates our commitment to providing the world’s 7 billion people with access to medicine and our continued leadership in enhancing access to ARVs to patients in developing countries," Mylan CEO Heather Bresch said. "This new flavored, pediatric formulation is designed to help parents and caregivers give accurate doses of the medication depending on the weight of the child. The innovative work being done at Mylan, in combination with our partnership with ViiV and CHAI, has enabled us to develop this new product to treat children with HIV, a particularly vulnerable population."

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 pediatric 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 pediatric formulation, moving from concept to FDA tentative approval in less than two years. The new, flavored 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 pediatric 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.