Half-dose Kaletra tablet approved for paediatric use in the US
On 9 November 2007, the FDA approved a new half-strength lopinavir/r (Kaletra) tablet formulation, manufactured by Abbott Laboratories.
Each film-coated tablet of this new formulation 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 minimise the risk for medication errors and overdose or under dose, and the addition of tablet dosing to section 2.2 Pediatric Patients.
In a press release, Abbott announced that it would make the lower strength formulation available in resource-poor countries, where Kaletra is marketed under the brand name Aluvia.
This wider access programme is dependent on European approval. The timeline for the EMEA decision is unclear.
Sources: FDA list serve and Abbott press release (12 Nov 07)