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A new half-strength Kaletra formulation approved

Food and Drug Administration - November 16, 2007
Richard Klein & Kimberly Struble

On November 9, 2007, FDA approved a new half-strength Kaletra tablet formulation. Each film-coated tablet contains 100 mg lopinavir and 25 mg ritonavir. The major changes to the label include clear instructions regarding the importance of accurate calculation of the dose of Kaletra to minimize the risk for medication errors and overdose or under dose, and the addition of tablet dosing to section 2.2 Pediatric Patients as described in the pdf attachment.

Kaletra is a combination protease inhibitor product containing lopinavir and ritonavir, manufactured by Abbott Laboratories. The original formulation was approved on September 15, 2000.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


071116
FD071105

SOURCE: Food and Drug Administration (FDA).

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