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 Emergency Dispensing Information (FDA Emergency Dispensing Order and CDC Emergency Use Instructions)
• Ciprofloxacin Use by Pregnant and Lactating Women

Doxycycline and Other Tetracyclines

• Questions and Answers for Consumers on Doxycycline
• Doxycycline Emergency Dispensing Information (FDA  Emergency Dispensing Order and CDC Emergency Use Instructions, including home preparation instructions)
• 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)
• Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles – draft guidance for government public health and emergency response stakeholders (2017)
• 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 and Penicillin G Procaine for Inhalational Anthrax (Post-Exposure)

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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

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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• Anthrax:  Developing Drugs for Prophylaxis of Inhalational Anthrax draft Guidance for Industry (2018)

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