FDA Updates Efavirenz Labeling With Expanded Pediatric Indication Information
May 7, 2013
"On May 2, 2013, the FDA expanded the indication for Sustiva (efavirenz) to include pediatric patients at least three months old and weighing at least 3.5 kg. For pediatric patients who cannot swallow capsules, the capsule contents can be administered with a small amount of food or infant formula using the capsule sprinkle method of administration.
"The updated labeling includes a table for dosing along with the corresponding number of capsules or tablets and strength to administer."
Other sections of the label that have been updated include the following: Warnings and Precautions, Adverse Reactions, Pediatric Use, Pharmacokinetics, and Clinical Studies.
The updated labeling will be available at the FDA website.
More information is available:
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