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FDA Approves IV Form of TPOXX for Smallpox

May 27, 2022

The FDA has approved SIGA Technologies’ intravenous formulation of TPOXX (tecovirimat) for the treatment of smallpox.

The agency previously approved TPOXX in oral form in July 2018 as the first drug indicated for treatment of smallpox. But the new approval gives an option for those who are unable to swallow oral capsules of the drug, the company said.

The small-molecule drug, which works by blocking cellular transmission of the virus, is part of the U.S. government’s Strategic National Stockpile, intended for use in the event of a smallpox bioterror attack.

SIGA said the drug could also be used in the treatment of monkeypox, which the Centers for Disease Control and Prevention has identified in seven U.S. states — part of an outbreak that has hit 16 countries in recent weeks.

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