← FDA DRUG APPROVALS

FDA NDA · NDA203050

POSFREA

palonosetron

Sponsor: AVYXA HOLDINGS

APPLICATION
NDA203050
TYPE
NDA
ORIGINAL APPROVAL
2016-03-01
LATEST ACTION
2025-04-16
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

POSFREA · ReferenceDiscontinued
PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) · SOLUTION · INTRAVENOUS
POSFREA · ReferencePrescription
PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-04-16Efficacy · Supplement 3 · standard — Label ↗AP
2024-07-17Labeling · Supplement 2 · standard — Letter ↗AP
2016-03-01Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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