Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 25MG BASE | 1 | VITRAKVI | LAROTRECTINIB SULFATE |
| 002 | CAPSULE;ORAL | EQ 100MG BASE | 1 | VITRAKVI | LAROTRECTINIB SULFATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-11-26 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2021-03-25 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-03-25 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-11-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Orphan | 5 |
| SUPPL | 8 | Null | 6 |
CDER Filings
BAYER HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 210861
[companyName] => BAYER HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"VITRAKVI","activeIngredients":"LAROTRECTINIB SULFATE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VITRAKVI","activeIngredients":"LAROTRECTINIB SULFATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/23\/2022","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/210861s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/210861s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/26\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210861s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/26\/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\\\/210861s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210861Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210861Orig1s000_21171Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"11\/23\/2022","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/210861s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/210861Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"03\/25\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/210861s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/210861Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"03\/25\/2021","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/210861Orig1s004ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2022-11-23
)
)