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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217684
Company: PYROS PHARMS

Medication Guide

Products on NDA 217684

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIGAFYDE	VIGABATRIN	100MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217684s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217684Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/217684Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2025	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217684s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217684Orig1s002, s004ltr.pdf
09/03/2025	SUPPL-2	Efficacy-New Route Of Administration	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217684s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217684Orig1s002, s004ltr.pdf
09/12/2024	SUPPL-1	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217684Orig1s001ltr.pdf

Labels for NDA 217684

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217684s002s004lbl.pdf
09/03/2025	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217684s002s004lbl.pdf
09/03/2025	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217684s002s004lbl.pdf
09/03/2025	SUPPL-2	Efficacy-New Route Of Administration	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217684s002s004lbl.pdf
06/17/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217684s000lbl.pdf

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