TIGECYCLINE | N021821 | PF PRISM CV
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2015-00873 | 7879828 | IPR | Apotex Inc. et al. | Institution Denied | 2015-03-12 | — |
| IPR2014-01259 | 7879828 | IPR | Initiative for Responsibility in Drug Pricing LLC | Institution Denied | 2014-08-08 | — |
| IPR2014-00115 | 7879828 | IPR | Apotex Inc. et al. | Final Written Decision | 2013-11-01 | — |
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Freyr Inc. FDA-2018-P-4340 · 5 docket documents Freyr Inc. submitted this petition pursuant to section 505(j)(2)(C) of the FD&C Act requesting that the FDA determine Tigecycline for Injection, 50 mg/vial containing 82.6 mg of arginine as a stabilizing agent is suitable for submission as an ANDA, noting that this same composition was already appro | Other | 2018-11-14 | Open | Freyr Inc. |
Citizen Petition from Freyr Inc. FDA-2017-P-6809 · 4 docket documents Freyr Inc. filed this suitability petition on behalf of a client requesting that the FDA designate Tigecycline for Injection 50 mg/vial marketed by Fresenius Kabi USA LLC (NDA 205645) as an additional Reference Listed Drug under section 505(j), enabling ANDA applicants to reference this product desp | Other | 2017-12-12 | Granted | Freyr Inc. |
Public Citizen's Health Research Group - Citizen Petition FDA-2011-P-0785 · 7 docket documents Public Citizen's Health Research Group filed this petition requesting that the FDA immediately add a black box warning to tigecycline (Tygacil, Pfizer) labeling regarding its increased risk of death compared to other antibiotics, distribute an FDA-approved Medication Guide warning patients about thi | Other | 2011-11-04 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.