General MedicationsINTRAVENOUSGeneric

POSFREA

PALONOSETRON HYDROCHLORIDE

Standard Dose

EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview POSFREA is listed in Drugs@FDA under application 203050 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient PALONOSETRON HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Sponsor AVYXA HOLDINGS Submission history Latest submission status date: 2025-04-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview POSFREA is listed in Drugs@FDA under application 203050 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient PALONOSETRON HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Sponsor AVYXA HOLDINGS Submission history Latest submission status date: 2025-04-16 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.