Aptalis Pharmaceutical Technologies announced that the European Commission has approved the marketing authorization of new oral granule formulation of Gilead Sciences' Viread, covering 27 countries of the European Union.
Viread is indicated for HIV-1 infected children between two to six years of age and for HIV-1 infected children more than six years for whom solid dosage is not suitable.
The new pediatric formulation was co-developed with Gilead Sciences, leveraging Aptalis' Microcaps taste-masking technology.
Aptalis Pharmatech will manufacture and supply the oralpowder to Gilead, which will take up commercialization activities.
Aptalis Pharma president John Fraher said the FDA and European Commission approved Gilead's Viread's oral granule formulation in the US and Europe respectively.
"To this end, we are pleased to have had the opportunity to co-develop the pediatric oral powder formulation of Viread with Gilead using our Microcaps proprietary technology," Fraher added.
