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Antimicrobial Drugs Advisory Committee

On Tuesday, May 1, 2018, the Antimicrobial Drugs Advisory Committee (AMDAC) discussed and voted on a new drug application (NDA) for TPOXX (tecovirimat), sponsored by SIGA Technologies Inc. (SIGA), for the proposed indication of the treatment of smallpox disease caused by variola virus in adults and pediatric patients.

The Committee voted unanimously (17 of 17 members) that the available data for TPOXX (tecovirimat) support the risk-benefit profile for the proposed use to treat human smallpox.