Comirnaty Booster Dose Authorization Expanded
May 17, 2022Vidaza Approved for Rare Pediatric Blood Cancer
May 20, 2022May 19, 2022 – Tpoxx® (tecovirimat – SIGA Technologies) has received an expanded smallpox treatment indication, as well as FDA approval of a new dosage formulation. Tpoxx is now approved for pediatric patients who weigh as little as 3kg (6.6 pounds) and comes in oral capsule and intravenous formulations.
- The U.S. FDA approved Tpoxx oral capsules in 2018 to treat human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13kg (28.7 pounds). The new intravenous solution allows Tpoxx to be used in patients who are unable to swallow capsules.
- Recommended dosing is based on the patient’s age, weight, and ability to swallow capsules.
- Although naturally occurring smallpox has been eradicated since 1980, the disease remains of concern to the U.S. FDA as a potential bioweapon.