fidaxomicin

Details

Files

Generic Name:

fidaxomicin

Project Status:

Complete

Therapeutic Area:

Clostridioides difficile infection

Manufacturer:

N/A

Call for patient/clinician input open:

November 21, 2024

Brand Name:

N/A

Project Line:

Reimbursement Review

Project Number:

SX0754-000

Call for patient/clinician input closed:

January 17, 2025

NOC Status at Filing:

N/A

Biosimilar:

Submission Type:

Non-sponsored Submission

Submission Complexity:

Standard Review

Fee Schedule:

N/A

Indications:

For the treatment of adults with Clostridioides difficile infection.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Key Milestones²
Milestones title	Date
Submission received	November 22, 2024
Expert committee meeting (initial)	May 15, 2025
Draft recommendation posted for stakeholder feedback	June 05, 2025
End of feedback period	June 19, 2025
Final recommendation posted	July 28, 2025
CDA-AMC review report(s) posted	July 28, 2025