Products Approved for Anthrax

• Anthim (obiltoxaximab) injection, for intravenous use
  • FDA approves Anthim for treatment of inhalational anthrax
  • Drug Trials Snapshot:  Anthim
• Anthrasil [Anthrax Immune Globulin Intravenous (Human)], sterile solution for infusion (CBER)
  • FDA approves Anthrasil for treatment of inhalational anthrax
• Biothrax (Anthrax Vaccine Adsorbed) (CBER)
  • FDA approves Biothrax vaccine for use after known or suspected anthrax exposure
• Ciprofloxacin
  • Ciprofloxacin Use by Pregnant and Lactating Women
  • Ciprofloxacin Emergency Dispensing Information
• Doxycycline and Other Tetracyclines
  • Questions and Answers for Consumers on Doxycycline
  • Public Health Emergency Home Preparation Instructions for Doxycycline.  Includes the pamphlet, "In an Emergency: How to Prepare Doxycycline for Children and Adults Who Cannot Swallow Pills"
  • Palatability Evaluations of Doxycycline Solid Dosage Tablets Ground and Mixed in Food or Drinks
  • Stability and Dose Uniformity Evaluations of Doxycycline Solid Dosage Tablets Ground and Mixed in Food or Drinks
  • Doxycycline Use by Pregnant and Lactating Women
  • Doxycycline Emergency Dispensing Information
  • Anthrax:  Doxycycline Mass Dispensing EUA Information
  • Expiry Date Extensions of Certain Lots of Doxycycline Hyclate 100mg Capsules Held in Strategic Stockpiles (FDA Memo to State and Local Public Health Agencies and First Responder Stakeholders)
  • Doxycycline and Penicillin G Procaine for Inhalational Anthrax (Post-Exposure)
  • Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles – draft guidance for government public health and emergency response stakeholders (2017)
• Levofloxacin
• Penicillin G Potassium
• Penicillin G Procaine
  • Doxycycline and Penicillin G Procaine for Inhalational Anthrax (Post-Exposure)
  • Questions and Answers for Consumers on Penicillin G Procaine
• Penicillin G Sodium
• Raxibacumab
  • FDA approves raxibacumab to treat inhalational anthrax

Considerations in Pediatrics, Pregnancy, and Lactation

• Amoxicillin
  • Commentary on Non-Labeled Dosing of Oral Amoxicillin in Adults and Pediatrics for Post-Exposure Inhalational Anthrax
  • Amoxicillin Use by Pregnant and Lactating Women
  • Safety of Long Term Therapy with Penicillin and Penicillin Derivatives

Product Development Guidance

• Anthrax:  Developing Drugs for Prophylaxis of Inhalational Anthrax draft Guidance for Industry (2016)