CAPECITABINE | N020896 | CHEPLAPHARM ARZNEIMITTEL GMBH
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2011-06-07 | Terminated 2011-09-20 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| 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 Lachman Consultant Services, Inc. FDA-2013-P-1126 Lachman Consultant Services, Inc. filed this citizen petition on September 6, 2013, pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93, requesting that the FDA determine that Capecitabine Tablets in strengths of 300 mg and 1000 mg are suitable for submissi | Other | 2014-09-08 | Granted | Lachman Consultant Services, Inc. |
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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