Documents
Application Sponsors
| NDA 210563 | PHARMACYCLICS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 140MG | 1 | IMBRUVICA | IBRUTINIB |
| 002 | TABLET;ORAL | 280MG | 1 | IMBRUVICA | IBRUTINIB |
| 003 | TABLET;ORAL | 420MG | 1 | IMBRUVICA | IBRUTINIB |
| 004 | TABLET;ORAL | 560MG | 1 | IMBRUVICA | IBRUTINIB |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2018-02-16 | PRIORITY |
| EFFICACY; Efficacy | ORIG | 2 | AP | 2018-02-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-07-15 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-11-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2020-04-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-08-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2020-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-05-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2022-08-24 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2022-08-24 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2022-08-24 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| ORIG | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Orphan | 5 |
| SUPPL | 7 | Orphan | 5 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 7 |
CDER Filings
PHARMACYCLICS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210563
[companyName] => PHARMACYCLICS INC
[docInserts] => ["",""]
[products] => [{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"140MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"280MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"420MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"560MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/24\/2022","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205552s038,210563s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2022","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205552s036,210563s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2022","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205552s035,215063s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205552s033,210563s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2020","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205552s032,210563s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205552s031,210563s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2020","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205552s030,210563s006lblPI.pdf\"}]","notes":""},{"actionDate":"11\/21\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205552s029,210563s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205552s028,210563s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205552s026,210563s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2018","submission":"SUPPL-1","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210563s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2018","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210563-orig2lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210563s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"02\/16\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210563-orig2lbl.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210563Orig1s000,210563Orig2s000TOC.cfm\"}]","notes":">"},{"actionDate":"02\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210563s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210563Orig2s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210563Orig1s000,210563Orig2s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/24\/2022","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205552s038,210563s014lbl.pdf\"}]","notes":">"},{"actionDate":"08\/24\/2022","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/24\/2022","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205552s036,210563s012lbl.pdf\"}]","notes":">"},{"actionDate":"05\/11\/2022","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205552s035,215063s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/205552Orig1s035;%20215063Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"12\/22\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205552s033,210563s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205552Orig1s033,%20210563Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"12\/18\/2020","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205552s032,210563s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/07\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205552s031,210563s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205552Orig1s031,210563Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"04\/21\/2020","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205552s030,210563s006lblPI.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205552Orig1s030,210563Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"11\/21\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205552s029,210563s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/15\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205552s028,210563s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"01\/25\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205552s026,210563s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205552Orig1s026,210563Orig1s002Ltr.pdf\"}]","notes":">"},{"actionDate":"08\/24\/2018","submission":"SUPPL-1","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210563s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205552Orig1s024,210563Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2022-08-24
)
)