Mylan granted tentative approval for pediatric formulation of abacavir/lamivudine tabs

LONDON and PITTSBURGH — Mylan on Thursday announced that its subsidiary, Mylan Labs, was granted tentative approval from the Food and Drug Administration for two dosages of abacavir/lamivudine tablets for oral suspension. The tablets are used to treat HIV-1 infection in pediatric patients. This marks the first version of abacavir/lamivudine with scoring to allow for dosage adjustment; it also is flavored. 

 

The approval is part of a 2012 agreement among Mylan, Clinton Health Access Initiative and ViiV Healthcare to transfer technology and resources to allow for production and distribution of the medication (at a low cost) to more than 100 "resource-limited" countries, including sub-Saharan Africa. The tablets  — which Mylan said will be available for purchase in early 2015 — come in 60-mg and 120-mg dosage strengths. 

 

"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."

 

More than 70% of the 3.4 million children living with HIV worldwide do not have access to proper care and medicines, Mylan said, citing data from a WHO, UNAIDS and UNICEF, Global HIV/AIDS response report. 

 

"The new, flavured 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," said David Ripin, EVP and chief scientific officer for CHAI.