ORLISTAT | N021887 | HALEON US HOLDINGS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Public Citizen's Health Research Group - Ctitizen Petition FDA-2011-P-0297 · 4 docket documents Public Citizen's Health Research Group, represented by Michael Carome, filed a citizen petition pursuant to 21 U.S.C. Section 355(e)(3) requesting that the FDA immediately ban both the prescription drug Xenical (orlistat) and the over-the-counter drug Alli (orlistat) because they expose patients to | Other | 2011-05-05 | Denied | — |
Public Citizen FDA-2006-P-0326 · 6 docket documents Public Citizen filed this petition pursuant to 21 U.S.C. Section 355(e)(3) requesting that the FDA immediately remove prescription Xenical (orlistat) from the market because the drug causes a significant increase in aberrant crypt foci in rat colons, which are believed to be precursors to colon canc | 505(q) | 2009-04-23 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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