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.
- Smallpox is a highly contagious disease caused by the variola virus, which belongs to the orthopoxvirus family of viruses. Tembexa inhibits orthopoxvirus replication by inhibiting viral DNA polymerase-mediated synthesis of viral DNA.
- Tembexa is administered once weekly for 2 doses, on Days 1 and 8.
- The Tembexa product label carries a boxed warning for increased risk for mortality when used for a duration longer than at the recommended dosage.
- Common adverse reactions include diarrhea, nausea, vomiting, and abdominal pain.
Development timeline for Tembexa
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