Roche announced that the FDA has approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with chronic renal failure (CRF) in adults, including patients on dialysis and patients not on dialysis. CRF is commonly known as chronic kidney disease (CKD). Mircera is the only FDA-approved erythropoiesis-stimulating agent (ESA) to provide correction of anemia with once-every-two-week dosing. Mircera is also the only FDA-approved ESA to maintain stable hemoglobin levels with once-monthly or once-every-two-week dosing in CKD patients.
Abbott announced that it has received FDA approval for a new lower-strength tablet formulation of its leading HIV protease inhibitor, Kaletra (lopinavir/ritonavir). The lower-strength Kaletra tablets will be available in the US this month. The new tablet formulation will complement Kaletra oral solution, which has been available for pediatric use since its approval in September 2000 in the US. For pediatric patients, lower-strength Kaletra tablets will offer more dosing flexibility and contains 100 mg of lopinavir and 25 mg of ritonavir, compared with the original tablet strength of 200 mg of lopinavir and 50 mg of ritonavir, most commonly used by adults.