First paediatric fixed dose triple combination (Pedimune) is approved by FDA for use in PEPFAR
Polly Clayden, HIV i-Base
On 13 August 2007, the FDA granted tentative approval for purchase under PEPFAR of Pedimune baby, the paediatric triple fixed-dose combination (FDC) of 3TC, d4T and nevirapine.
This is the first fixed-dose antiretroviral product designed to treat children under the age of 12 years.
As with adult FDCs containing nevirapine, paediatric patients can use it twice daily once they have 14 days of lead-in treatment with nevirapine, taken once daily. The tablet can also be dissolved in water for children who cannot swallow pills.
As a result of this approval the FDC will be also included on the list maintained by the WHO prequalification programme.
Source: FDA website