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Odactra Approval History

Reviewed on Mar 1, 2017 by J.Stewart BPharm.

  • FDA approved: Yes (First approved March 1st, 2017)
  • Brand name: Odactra
  • Generic name: house dust mite allergen extract
  • Dosage form: Sublingual Tablets
  • Company: ALK-Abelló A/S
  • Treatment for: Allergic Rhinitis

Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis.

Odactra is for use in adults 18 through 65 years who have a confirmed allergy to house dust mites. The FDA approval of Odactra was based on the results of four double-blind, placebo-controlled, randomized clinical studies of 1279 patients. Patients who took Odactra experienced a 16 to 18 percent reduction in symptoms compared to those who received a placebo.

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 comes with a boxed warning to alert health care professionals and patients of the risk of severe allergic reactions, and the first dose must be administered under medical supervision. Common side effects include nausea, itching in the ears and mouth, and swelling of the lips and tongue.

Development History and FDA Approval Process for Odactra

Mar  1, 2017Approval FDA Approves Odactra for House Dust Mite Allergies
Apr 12, 2016Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet

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