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FDA approves Cipla’s Lopinavir/ritonavir for AIDS in infants and young children

Thursday, June 4, 2015

Cipla, a global pharmaceutical company, has received FDA approval for Lopinavir/ritonavir (LPV/r) 40mg/10mg oral pellets for paediatric specific treatment for infants.

Cipla has long recognized the lack of access to life saving child-friendly formulations for the treatment of HIV, which prompted it to develop an innovative formulation of LPV/r oral pellets. The pellets are to be sprinkled on sweetened porridge for infants and administered to them. The pellets are produced by melt-extrusion technology and are enclosed in capsules.

Cipla has been working for many years in collaboration with Diana Gibb, professor of epidemiology, senior program leader and honorary consultant pediatrician at Medical Research Council Clinical Trials Unit at UCL (University College London) toward development of this novel child-friendly formulation, which has been approved by FDA under the President’s Emergency Plan for AIDS Relief (PEPFAR) program.

Globally 3,200,000 children were living with HIV in 2013 and 240,000 children were newly infected with HIV. Although antiretroviral therapy can be life saving for these children, only 24% currently are on treatment. One third of the children born with HIV without treatment die before their first birthday and 50% die before they turn two.

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