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  8. Withdrawn | Infectious Disease Accelerated Approvals
  1. Accelerated Approval Program

Withdrawn | Infectious Disease Accelerated Approvals

This listing includes accelerated approvals (AAs) for infectious disease indications that have postmarketing requirement(s) that have been subsequently withdrawn, and are therefore, no longer FDA-approved.

Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling.

Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. See Postmarket Requirements and Commitments for the status of specific requirements. 

Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.

Proprietary Name Accelerated Approval Indication Accelerated Approval Date Full Approval Conversion-Withdrawal Date

Sulfamylon (mafenide acetate)

 For use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds 6/5/1998 11/30/2022
Levaquin (levofloxacin) To reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis in pediatric patients (>= 6 months of age and older) 5/5/2008 7/21/2017
Levaquin (oral solution; levofloxacin) To reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis in pediatric patients (>=6 months of age and older) 5/5/2008 7/21/2017
Levaquin (levofloxacin) To reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis in pediatric patients (>=6 months of age and older) 11/24/2004 1/22/2021
Levaquin (levofloxacin) For the treatment of inhalational anthrax (post-exposure) 11/24/2004 7/21/2017
Levaquin (oral solution; levofloxacin) For the treatment of inhalational anthrax (post-exposure) 11/24/2004 7/21/2017
Levaquin (levofloxacin) To reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis in pediatric patients (>= 6 months of age and older) 5/5/2008 1/22/2021
Cipro (ciprofloxacin) For the treatment of inhalational anthrax (post-exposure) 8/30/2000 6/4/2004
Synercid (dalfopristin/quinupristin) For the treatment of vancomycin-resistant enterococcus faecium (VREF)  9/21/1999 11/12/2010 1
  • 1Federal Register Date, which may be different than applicant submission or FDA action date
 
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