Withdrawn | Infectious Disease Accelerated Approvals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approvals (AAs) for infectious disease indications that have postmarketing requirement(s) that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling.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Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.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 |
|---|---|---|---|
| Ixchiq (Chikungunya Vaccine, Live) | Active immunization for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus | 11/9/2023 | 1/29/2026 1 |
| Ixchiq (Chikungunya Vaccine, Live) | Active immunization for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus | 11/9/2023 | 1/29/2026 1 |
| 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 2 |
- 1 a b The two entries for Ixchiq represent two different postmarketing requirements that were released when Ixchiq was withdrawn. For more information, see https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-permanent-discontinuations
- 2Federal Register Date, which may be different than applicant submission or FDA action date