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2010-09-24
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Prescription Drug Products; Doxycycline and Penicillin G Procaine Administration for Inhalational Anthrax (Post-Exposure)
Notices
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D09002ee1bdf51b81
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is clarifying that the currently approved indications for doxycycline and penicillin G procaine drug products include use in cases of inhalational exposure to Bacillus anthracis (the bacterium that causes anthrax). We also are providing dosing regimens that we have determined are appropriate for these products for this use. We encourage the submission of supplemental new drug applications (labeling supplements) to add the dosage information to the labeling of currently marketed drug products.
66 FR 55679
https://www.govinfo.gov/app/details/FR-2001-11-02/01-27493
01-27493
fr02no01-85
4160-01-S
Docket No. 01N-0494
https://www.govinfo.gov/app/details/FR-2001-11-02/01-27493
https://www.govinfo.gov/content/pkg/FR-2001-11-02/html/01-27493.htm
https://www.govinfo.gov/content/pkg/FR-2001-11-02/pdf/01-27493.pdf
4 p.
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66 FR 55679
Prescription Drug Products; Doxycycline and Penicillin G Procaine Administration for Inhalational Anthrax (Post-Exposure); Federal Register Vol. 66, Issue
NOTICE
01-27493
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 01N-0494
4160-01-S
01-27493
Notice.
The Food and Drug Administration (FDA) is clarifying that the currently approved indications for doxycycline and penicillin G procaine drug products include use in cases of inhalational exposure to Bacillus anthracis (the bacterium that causes anthrax). We also are providing dosing regimens that we have determined are appropriate for these products for this use. We encourage the submission of supplemental new drug applications (labeling supplements) to add the dosage information to the labeling of currently marketed drug products.
Dianne Murphy, Center for Drug Evaluation and Research (HFD-950), Food and DrugAdministration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2350.
Human drugs:
Prescription drug products
Anthrax inhalation exposure; doxycycline and penicillin G procaine administration,
www.fda.gov/cder/drug/infopage/penG_doxy/bibliolist.htm
Federal Register
Vol. 66, no. 213
Office of the Federal Register, National Archives and Records Administration
2001-11-02
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325 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2001-11-02
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https://www.govinfo.gov/app/details/FR-2001-11-02
https://www.govinfo.gov/content/pkg/FR-2001-11-02/pdf/FR-2001-11-02.pdf
https://www.govinfo.gov/content/pkg/FR-2001-11-02/xml/FR-2001-11-02.xml
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2010-09-24
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