ODACTRA
STN: 125592
Proper Name: House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract
Tradename: ODACTRA
Manufacturer: ALK-Abello A/S
Indication:
- Immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in adults 18 through 65 years of age
Product Information
- Package Insert - ODACTRA
- Demographic Subgroup Information - ODACTRA
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- September 9, 2020 Approval Letter - ODACTRA
- February 26, 2020 Approval Letter - ODACTRA
- March 1, 2017 Approval Letter - ODACTRA
- March 1, 2017 Summary Basis for Regulatory Action - ODACTRA
- Approval History, Letters, Reviews, and Related Documents - ODACTRA