Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 15MG | 1 | COPIKTRA | DUVELISIB |
| 002 | CAPSULE;ORAL | 25MG | 1 | COPIKTRA | DUVELISIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-09-24 | PRIORITY |
| EFFICACY; Efficacy | ORIG | 2 | AP | 2018-09-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-12-17 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2022-02-02 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| ORIG | 2 | Null | 2 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
CDER Filings
VERASTEM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 211155
[companyName] => VERASTEM INC
[docInserts] => ["",""]
[products] => [{"drugName":"COPIKTRA","activeIngredients":"DUVELISIB","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"COPIKTRA","activeIngredients":"DUVELISIB","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/26\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211155s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211155s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/24\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211155Orig2s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/211155Orig1Orig2s000TOC.cfm\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211155s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211155Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/211155Orig1Orig2s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"09\/26\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211155s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211155Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-09-26
)
)