STN: 125592
Proper Name: House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract
Tradename: ODACTRA
Manufacturer: ALK-Abello A/S, Horshlom Denmark
Indication:
- House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract is 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 5 through 65 years of age.
Product Information
Supporting Documents
- February 27, 2025 Approval Letter – ODACTRA
- December 1, 2023 Approval Letter – ODACTRA
- 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
Related Information
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Content current as of:
02/27/2025
