FDA grants approval of dispersible tablet formulation of dolutegravir and extension of paediatric indication for HIV

The new formulation is approved for patients aged at least 4 weeks old and weighing at least 3 kg. Supporting data demonstrated that the safety, effectiveness and pharmacokinetics of dolutegravir were comparable to adults taking dolutegravir.

SPS commentary:

In the UK, dolutegravir is currently available in solid tablet formulation for the treatment of HIV in children aged 6 years and older.