CAPECITABINE | A090943 | RISING PHARMA HOLDING INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kenneth E. Surprenant FDA-2020-P-2213 Kenneth E. Surprenant filed this citizen petition requesting that the FDA revise the package inserts for Fluorouracil and Xeloda (Capecitabine) to recommend pre-treatment testing for dihydropyrimidine dehydrogenase (DPD) deficiency, shift responsibility for identifying DPD deficiency from patients t | Other | 2020-11-19 | Partially Denied | Kenneth E. Surprenant |
Acknowledgment Letter from FDA DMS to Kenneth E. Surprenant FDA-2020-P-2213 Kenneth E. Surprenant filed a petition requesting that the FDA revise the drug labels for Fluorouracil and Xeloda (Capecitabine) to recommend pre-treatment testing for Dihydropyrimidine Dehydrogenase (DPD) deficiency, shift responsibility for identifying DPD deficiency from patients to prescribing p | Other | 2020-11-19 | Partially Denied | — |
Citizen Petition From Ken Surprenant FDA-2014-P-0497 Ken Surprenant filed this citizen petition on April 19, 2014, requesting that the FDA revise the Warnings and Precautions section of the package insert for Xeloda (capecitabine) to include information about dihydropyrimidine dehydrogenase (DPD) deficiency as a risk factor for severe toxicity and fat | Other | 2014-04-24 | Partially Denied | Ken Surprenant |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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