LEVOFLOXACIN | N020634 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from David Melvin FDA-2023-P-4222 · 3 docket documents Linda Martin, David Melvin, and Michael Mendoza filed this citizen petition under sections 505(o)(4) and 505-1(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require all fluoroquinolone antibiotics, including Levaquin (levofloxacin, NDA 020634) and Cipro (ciprofloxacin, | Other | 2023-09-28 | Open | David Melvin |
Citizen Petition from SONAR FDA-2019-P-2998 · 7 docket documents The Southern Network For Adverse Reactions filed this citizen petition under sections 505(o)(4) and 505-1(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA add a black box warning for Fluoroquinolone-Associated Disability and psychiatric adverse events including suicide to | Other | 2019-06-21 | Denied | SONAR |
Citizen Petition from Southern Network on Adverse Reactions SONAR FDA-2014-P-1611 · 5 docket documents Southern Network on Adverse Reactions (SONAR) filed this citizen petition under section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA modify the professional labeling for Levaquin (levofloxacin), NDA 020634, to add psychiatric adverse events to the warnings and precau | Other | 2014-10-15 | Partially Denied | Southern Network on Adverse Reactions SONAR |
Citizen Petition from the Southern Network on Adverse Reactions FDA-2014-P-0856 · 7 docket documents The Southern Network on Adverse Reactions filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA change the professional labeling for Levaquin (levofloxacin), NDA 020634, manufactured by Johnson & Johnson, to add information about possible m | Other | 2014-07-17 | Denied | the Southern Network on Adverse Reactions |
Office of Illinois Attorney General FDA-2005-P-0064 · 6 docket documents The Office of the Illinois Attorney General, filed this citizen petition on May 18, 2005, requesting that the FDA require manufacturers of fluoroquinolone antibiotics (ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin, and moxifloxacin) to strengthen labeling warnings about tendonopathy and tendo | Other | 2005-05-24 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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