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FDA approves Gilead HIV drug NDA

The US Food and Drug Administration (FDA) has approved a new drug application (NDA) for Gilead Sciences' Viread (tenofovir disoproxil fumarate), an oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients.

Aptalis Pharma and Gilead have co-developed the oral powder formulation of Viread using the Aptalis Microcaps taste-masking technology.

The Aptalis microencapsulation technology, known as Microcaps, employs versatile and precise coating techniques to encapsulate individual drug particles using solvent- and aqueous-based coacervation.

Gilead will be responsible for the product commercialization, while Aptalis will manufacture and supply the oral powder to Gilead.