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U.S. - Corporate press release: FDA Approves Expanded Smallpox - Monkeypox Treatment Formulation

Mary Wilson

Well-known member
May 19, 2022 • 12:12 pm CDT

Precision Vaccinations

New York-based SIGA Technologies, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the intravenous (IV) formulation of TPOXX for the treatment of smallpox.

SIGA stated in its press release issued on May 19, 2022, that the IV formulation is an essential option for those unable to swallow the oral capsules of TPOXX.

The oral formulation of TPOXX (tecovirimat) is approved in the U.S., Canada, and Europe.

TPOXX worldwide approvals include the treatment of smallpox, monkeypox, cowpox, and complications from immunization with vaccinia.

Recently, SIGA announced that it had initiated clinical programs to support oral TPOXX label expansion for Post-Exposure Prophylaxis.

And from an availability perspective, SIGA announced on May 12, 2022, that the U.S. Department of Defense (DoD) awarded a contract to SIGA for the procurement of up to approximately $7.5 million of oral TPOXX, of which approximately $3.6 million of oral TPOXX targeted for delivery in 2022.

“We are grateful to the FDA for their work leading to approval of IV TPOXX, which will provide access to a broader patient population,” commented Dr. Dennis Hruby, CSO of SIGA ...

https://www.precisionvaccinations.c...nded-smallpox-monkeypox-treatment-formulation
 
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