FDA ten­ta­tive­ly ap­proves gener­ic ver­sion of pe­di­atric HIV drug un­der PEP­FAR pro­gram

The FDA on Tues­day ten­ta­tive­ly ap­proved a pe­di­atric ver­sion of an HIV-1 treat­ment fol­low­ing a suc­cess­ful pub­lic-pri­vate part­ner­ship be­tween the Clin­ton Health Ac­cess Ini­tia­tive, Uni­taid, GSK’s Vi­iV Health­care and two Vi­a­tris sub­sidiaries — Au­robindo and My­lan.

The ten­ta­tive nod was made as part of the Pres­i­dent’s Emer­gency Plan for AIDS Re­lief (PEP­FAR) scheme, which will make ac­ces­si­ble a dis­persible for­mu­la­tion of the com­bo of an­tivi­rals aba­cavir, do­lute­gravir and lamivu­dine, for the treat­ment of HIV-1 in­fec­tion in pe­di­atric pa­tients at least 3 months old and weigh­ing be­tween 6 kg (13 lbs) and 25 kg (55 lbs) in low- and mid­dle-in­come coun­tries. No ex­act date was giv­en for when the drug will launch or win full FDA ap­proval.

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