GATIFLOXACIN | A079084 | APOTEX INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Senju Pharmaceutical Co. Ltd. et al v. Apotex Inc. et al 1 patentANDA 079084gatifloxacin | D. Del. | 2011-11-28 | Terminated 2012-09-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Public Citizen Health Research Group - Citizen Petition FDA-2006-P-0081 · 7 docket documents Public Citizen Health Research Group filed this petition pursuant to section 355(e)(3) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. 10.30, requesting that the FDA immediately ban gatifloxacin (Tequin, manufactured by Bristol-Myers-Squibb) due to significantly elevated risk of dysglycemi | Other | 2008-09-29 | Partially Denied | — |
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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