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Cipla gets US FDA approval for Lopinavir and ritonavir oral pellets

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Capital Market

For paediatric specific treatment for infants

Cipla announced that it has received US FDA approval for an innovative formulation Lopinavir/ ritonavir (LPV/r) 40mg/ 10 mg 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 Programme Leader and Honorary Consultant Paediatrician at Medical Research Council Clinical Trials Unit at UCL (University College London) towards development of this novel child-friendly formulation which has been approved by US FDA under the President's Emergency Plan for AIDS Relief (PEPFAR) program.

 

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First Published: Jun 03 2015 | 3:55 PM IST

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