FDA approves Bristol-Myers Squibb's Sustiva for HIV in infants, toddlers

Drug approved for patients as young as 3 months

PRINCETON, N.J. — The Food and Drug Administration has approved a drug for HIV in infants and toddlers.

Bristol-Myers Squibb said the FDA approved Sustiva (efavirenz) for HIV-1 in pediatric patients as young as 3 months and weighing at least 7.7 pounds. The approval includes a "capsule sprinkle" administration option for those who can't swallow capsules or tablets, whereby capsules are broken open and the contents are sprinkled on food or a beverage. The new approval was under a supplemental new drug application, or sNDA, which means the drug was approved for a new use in addition to approvals it had already received; the FDA originally approved Sustiva in 1998 for children ages 3 years and older.

"Bristol-Myers Squibb recognizes the importance of offering alternative methods of administration of HIV medicines, including for pediatric patients who cannot swallow tablets or capsules, and their caregivers who help manage their treatment," Bristol-Myers Squibb SVP global development and medical affairs Brian Daniels said. "This approval is one example of our enduring commitment to the HIV patient community."


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