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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211150
Company: HARMONY

Products on NDA 211150

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211150

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.html
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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2025	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211150s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211150Orig1s007ltr.pdf
02/13/2026	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211150s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/211150Orig1s006ltr.pdf
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

Labels for NDA 211150

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/13/2026	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211150s006lbl.pdf
05/23/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211150s007lbl.pdf
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

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