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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210661
Company: AVYXA HOLDINGS

Products on NDA 210661

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AXTLE	PEMETREXED DIPOTASSIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes
AXTLE	PEMETREXED DIPOTASSIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210661

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2024	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210661s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210661Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/210661Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2025	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210661s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210661Orig1s004ltr.pdf
06/18/2025	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210661Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210661Orig1s003ltr.pdf
12/02/2024	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210661s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210661Orig1s001ltr.pdf

Labels for NDA 210661

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2025	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210661s004lbl.pdf
06/18/2025	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210661Orig1s003lbl.pdf
06/18/2025	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210661Orig1s003lbl.pdf
06/18/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210661Orig1s003lbl.pdf
12/02/2024	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210661s001lbl.pdf
06/28/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210661s000lbl.pdf

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