Proper Name: House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract
Manufacturer: ALK-Abello A/S, Horshlom, Denmark
- ODACTRA is an allergen extract indicated as immunotherapy for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites or by positive skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in persons 12 through 65 years of age.
- Package Insert - ODACTRA
- Medication Guide - 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.
- January 20, 2023 Approval Letter - ODACTRA
- January 20,2023 Clinical Review Memo - ODACTRA
- Statistical Review - ODACTRA
- 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