FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Reports on Medical Countermeasures Initiative

April 17, 2019
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The FDA released a status report on its Medical Countermeasures Initiative (MCMi) that highlights fiscal year 2018 approvals of treatments or preventive measures aimed at chemical, biological, radiological and nuclear threats and emerging infectious diseases.

The agency approved 28 medical countermeasures, the report says, including the first drug indicated for treating smallpox, SIGA Technologies’ TPOXX (tecovirimat).

Other approvals included an expanded indication for GSK’s influenza virus vaccine Fluarix, which extends its age range to include children six to 35 months old, and a new indication for Partner Therapeutics’ Leukine (sargramostim), a medicine used to increase survival of adult and pediatric patients from birth to 17 years of age intensely exposed to radiation.

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