PERFLUTREN | N021064 | LANTHEUS MEDICAL IMAGING INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from International Contrast Ultrasound Society FDA-2018-P-3354 · 14 docket documents The International Contrast Ultrasound Society filed this citizen petition on August 29, 2018, requesting that the FDA remove the boxed warnings from the labels of ultrasound contrast agents (UCAs) Optison, Definity, and Lumason, arguing that peer-reviewed scientific data accumulated since 2007 demon | Other | 2018-09-05 | Denied | International Contrast Ultrasound Society |
International Contrast Ultrasound Society (ICUS) Steven Feinstein, et al - Ci... FDA-2011-P-0725 · 4 docket documents The International Contrast Ultrasound Society, represented by Steven Feinstein and others, filed this citizen petition under 21 C.F.R. §§ 10.30 and 201.57(c)(1) requesting that the FDA Commissioner remove boxed warnings from ultrasound contrast agents Definity and Optison, arguing that current scien | Other | 2011-10-11 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.