The Food and Drug Administration has extended approval of dolutegravir tablets for oral suspension to treat HIV in newborns, covering infants weighing at least 2 kilograms from birth up to 4 weeks of age. Until this week, the drug sold as Tivicay PD was approved only for infants 4 weeks and older weighing at least 3 kilograms.
The practical effect is narrow in the United States and significant worldwide. Roughly 4.4 pounds is now the lower weight boundary, and the first four weeks of life are now covered by a label rather than by clinical judgment alone.
