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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203050
Company: AVYXA HOLDINGS

Products on NDA 203050

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POSFREA	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
POSFREA	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203050

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203050s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203050Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203050Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203050Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2025	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203050s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203050Orig1s003ltr.pdf
07/17/2024	SUPPL-2	Labeling-Proprietary Name Change	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203050s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203050Orig1s002ltr.pdf

Labels for NDA 203050

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2025	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203050s003lbl.pdf
07/17/2024	SUPPL-2	Labeling-Proprietary Name Change	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203050s002lbl.pdf
03/01/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203050s000lbl.pdf

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