Documents
Application Sponsors
| NDA 213246 | LOXO ONCOLOGY INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 40MG | 2 | RETEVMO | SELPERCATINIB |
| 002 | CAPSULE;ORAL | 80MG | 2 | RETEVMO | SELPERCATINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-05-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2021-01-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2022-09-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2022-09-21 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 30 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 7 |
CDER Filings
LOXO ONCOLOGY INC
cder:Array
(
[0] => Array
(
[ApplNo] => 213246
[companyName] => LOXO ONCOLOGY INC
[docInserts] => ["",""]
[products] => [{"drugName":"RETEVMO","activeIngredients":"SELPERCATINIB","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"RETEVMO","activeIngredients":"SELPERCATINIB","strength":"80MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/08\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213246s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/08\/2020","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\\\/2020\\\/213246s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213246Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/213246Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-05-08
)
)