FDA Clears AbbVie to Produce Oral Powder form of Norvir


The powder form will be more easily administered to pediatric patients, AbbVie says.

The US Food and Drug Administration (FDA) has awarded approval to a new version of the HIV drug, ritonavir (Norvir) for treating pediatric patients.

The FDA made the announcement in a news release earlier this week that AbbVie will begin producing the drug in an oral powder form. The organization now approves of the antiretroviral in powder form for use with other similar agents, noting that the oral powder is only for >100 mg dose increments.

Roquel Powers, a spokeswoman for Abbvie, said the drug will better serve the patient population.

“AbbVie has a long-standing commitment to HIV and this commitment includes continuing to innovate to address unmet patient needs and provide added benefits to patients,” she said, adding that the oral powder form is “intended to maintain flexibility in administration options for pediatric HIV patients who cannot wallow Norvir tablets.”

Because this form of ritonavir doesn’t contain alcohol or propylene glycol, the FDA has deemed it safer for pediatric patients.

AbbVie will revise the labeling of the ritonavir tablet for oral use and the oral solution to reflect the addition of the new powder form. Physicians will soon be able to find revised labeling at DailyMed, the FDA says.

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