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DuPont Sustiva Liquid Pediatric NDA Imminent; Expanded Access Planned

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

DuPont will follow up on the Feb. 9 full approval of Sustiva (efavirenz) with an NDA for a liquid pediatric formulation of the HIV drug. The firm expects to submit the application in March or April. While awaiting approval, DuPont plans to make the liquid formulation available through an expanded access program.
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