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General MedicationsSUBCUTANEOUSStandard

VYLEESI (AUTOINJECTOR)

BREMELANOTIDE ACETATE

Standard Dose
EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview VYLEESI (AUTOINJECTOR) is listed in Drugs@FDA under application 210557 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BREMELANOTIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) Sponsor COSETTE Submission history Latest submission status date: 2020-10-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview VYLEESI (AUTOINJECTOR) is listed in Drugs@FDA under application 210557 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BREMELANOTIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) Sponsor COSETTE Submission history Latest submission status date: 2020-10-23 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.