ROSIGLITAZONE MALEATE | N021071 | WOODWARD PHARMA SERVICES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizens Petition from Public Citizen Health Group FDA-2000-P-1218 Public Citizen Health Group filed this citizen petition on March 7, 2000, pursuant to 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30, requesting that the FDA immediately require revised professional labeling for the thiazolidinedione diabetes drugs troglitazone (Rezulin), rosiglitazone (Avandia), a | Other | 2011-02-17 | Partially Denied | Public Citizen Health Group |
Public Citizen - Citizen Petition FDA-2008-P-0580 Public Citizen, a consumer advocacy organization representing over 80,000 consumers, filed this citizen petition on October 30, 2008, pursuant to 21 U.S.C. Section 355(e)(3) requesting that the FDA immediately ban Avandia (rosiglitazone) manufactured by GlaxoSmithKline due to serious safety risks in | Other | 2008-11-05 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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