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news.Abbott has said that that the European Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion recommending approval of a new, lower-strength tablet formulation of the company's lead HIV protease inhibitor, Kaletra.
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In addition, the CHMP has also adopted a positive opinion, in coordination with the World Health Organization (WHO), for Aluvia (lopinavir/ritonavir), the tradename of the same lower-strength tablet formulation in developing countries. The new lower-strength formulation is suitable for pediatric use and represents a significant breakthrough for clinicians and patients in developing countries.
The European Commission will review the CHMP’s positive opinion for Kaletra (lopinavir/ritonavir) and is expected to issue a final decision for marketing authorization for the lower-strength Kaletra in the EU within the next 60-90 days.