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Tembexa FDA Approval History

Last updated by Judith Stewart, BPharm on June 8, 2021.

FDA Approved: Yes (First approved June 4, 2021)
Brand name: Tembexa
Generic name: brincidofovir
Dosage form: Tablets and Oral Suspension
Company: Chimerix, Inc.
Treatment for: Smallpox

Tembexa (brincidofovir) is a nucleotide analog broad-spectrum antiviral indicated for use as a medical countermeasure for smallpox.

Development Timeline for Tembexa

DateArticle
Jun  4, 2021Approval  FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox
Dec  7, 2020Chimerix Announces FDA Acceptance of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
Apr 28, 2020Chimerix Receives FDA Clearance for Rolling Submission of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
Nov 13, 2014Chimerix's Brincidofovir Selected for Use in Ebola Clinical Trial in West Africa
Oct  6, 2014Chimerix Announces Emergency Investigational NDA for Brincidofovir Authorized by FDA for Patients With Ebola Virus Disease

Further information

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