Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211150
Company: HARMONY
Company: HARMONY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
WAKIX | PITOLISANT HYDROCHLORIDE | EQ 4.45MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
WAKIX | PITOLISANT HYDROCHLORIDE | EQ 17.8MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/13/2020 | ORIG-2 | Approval | Efficacy | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211150_Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211150Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000TOC.cfm | |
08/14/2019 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211150s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211150Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/21/2024 | SUPPL-6 |
Label is not available on this site. |
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06/21/2024 | SUPPL-5 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211150s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211150Orig1s005ltr.pdf | |
12/22/2022 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211150s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211150Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/21/2024 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211150s005s006lbl.pdf | |
12/22/2022 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211150s003lbl.pdf | |
10/13/2020 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211150_Orig2s000lbl.pdf | |
08/14/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211150s000lbl.pdf |