Proper Name: House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract Tablet for Sublingual Use
Manufacturer: Merck Sharp & Dohme Corp
- Indicated for use in adults 18 through 65 years of age as 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.
- 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.
- March 1, 2017 Approval Letter - ODACTRA
- March 1, 2017 Summary Basis for Regulatory Action - ODACTRA
- Approval History, Letters, Reviews, and Related Documents - ODACTRA