Odactra FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 28, 2025.
FDA Approved: Yes (First approved March 1, 2017)
Brand name: Odactra
Generic name: house dust mite allergen extract
Dosage form: Sublingual Tablets
Company: ALK-Abelló A/S
Treatment for: House Dust Mite Allergies
Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM) allergies.
- Odactra is indicated as immunotherapy for the treatment of 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 individuals 5 through 65 years of age.
- Odactra is a sublingual tablet taken once-daily, year round. The tablet dissolves within 10 seconds under the tongue, and patients should avoid swallowing for at least one minute, and avoid food or beverages for five minutes after each dose.
- Odactra carries a boxed warning to alert health care professionals and patients of the risk of severe allergic reactions. The first dose must be administered under medical supervision.
- Common solicited adverse reactions (≥10%):
- in adults 18-65 years of age include throat irritation/tickle, itching in the mouth, itching in the ear, swelling of the uvula/back of the mouth, swelling of the lips, swelling of the tongue, tongue pain, nausea, throat swelling, stomach pain, tongue ulcer/sore on the tongue, mouth ulcer/sore in the mouth, and food tastes different.
- in adolescents 12-17 years of age include throat irritation/tickle, itching in the mouth, itching in the ear, tongue pain, stomach pain, swelling of the uvula/back of the mouth, swelling of the lips, swelling of the tongue, throat swelling, nausea, tongue ulcer/sore on the tongue, and mouth ulcer/sore in the mouth, and diarrhea.
- children 5-11 years of age include itching in the mouth, throat irritation/tickle, itching in the ear, stomach pain, swelling of the lips, tongue pain, food tastes different, nausea, swelling in the back of the mouth, swelling of the tongue, and mouth ulcer.
Development timeline for Odactra
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.