New Drug Application (NDA): 216196
Company: AGIOS PHARMS INC

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AQVESME	MITAPIVAT SULFATE	EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
PYRUKYND	MITAPIVAT SULFATE	EQ 5MG BASE	TABLET;ORAL	Prescription	None	Yes	No
PYRUKYND	MITAPIVAT SULFATE	EQ 20MG BASE	TABLET;ORAL	Prescription	None	Yes	No
PYRUKYND	MITAPIVAT SULFATE	EQ 50MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2022	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216196s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216196Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/216196Orig1s000TOC.html

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
09/28/2026	SUPPL-7	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216196Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216196Orig1s007ltr.pdf
04/08/2026	SUPPL-6	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216196Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216196Orig1s006ltr.pdf
01/03/2025	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216196s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216196Orig1s004ltr.pdf
12/23/2025	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216196Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216196Orig1s003ltr.pdf

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2026	SUPPL-7	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216196Orig1s007lbl.pdf
04/08/2026	SUPPL-6	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216196Orig1s006lbl.pdf
12/23/2025	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216196Orig1s003lbl.pdf
01/03/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216196s004lbl.pdf
02/17/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216196s000lbl.pdf