Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 4.45MG BASE | 1 | WAKIX | PITOLISANT HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 17.8MG BASE | 1 | WAKIX | PITOLISANT HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-08-14 | PRIORITY |
| EFFICACY; Efficacy | ORIG | 2 | AP | 2020-10-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2022-12-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| ORIG | 2 | Null | 2 |
| SUPPL | 3 | Null | 6 |
CDER Filings
HARMONY
cder:Array
(
[0] => Array
(
[ApplNo] => 211150
[companyName] => HARMONY
[docInserts] => ["",""]
[products] => [{"drugName":"WAKIX","activeIngredients":"PITOLISANT HYDROCHLORIDE","strength":"EQ 4.45MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"WAKIX","activeIngredients":"PITOLISANT HYDROCHLORIDE","strength":"EQ 17.8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/13\/2020","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211150_Orig2s000lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211150s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/13\/2020","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211150_Orig2s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211150Orig2s000ltr.pdf\"}]","notes":">"},{"actionDate":"08\/14\/2019","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\\\/2019\\\/211150s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211150Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211150Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-10-13
)
)