Paediatric Kaletra tablet gains formal US approval

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A paediatric tablet formulation of the protease inhibitor lopinavir/ritonavir (Kaletra or Aluvia) has received approval from the Food and Drug Administration (FDA) in the United States.

The new tablet formulation of the drug will be available in the US later this year and contains 100mg of lopinavir and 25mg of ritonavir compared with the full adult tablet which contains 200mg of lopinavir and 50mg of ritonavir.

Like the adult tablet, the paediatric tablet formulation can be taken with or without food and does not require refrigeration (unlike the older Kaletra capsules).

Glossary

formulation

The physical form in which a drug is manufactured or administered. Examples of formulations include tablets, capsules, powders, and oral and injectable solutions. A drug may be available in multiple formulations.

paediatric

Of or relating to children.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

oral

Refers to the mouth, for example a medicine taken by mouth.

The paediatric tablet is urgently required in resource limited countries, where distribution, storage, refrigeration and dosing of liquid formulations can be challenging.

Furthermore, the need for a tablet formulation of Kaletra in richer countries was demonstrated earlier this year when a child died after being given an accidental overdose of the Kaletra oral solution.

Abbott intends to price the new paediatric formulation at $2100 per patient per year in the US and $250 per patient per year in developing countries.

European approval is expected soon and Abbott has reached an agreement with European drug regulatory authorities that will allow it supply the drug directly to clinicians in over 150 countries if it is requested.