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Allergenics

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The Center for Biologics Evaluation and Research (CBER) regulates allergenic products. There are currently three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests.

Allergen Extracts

Allergen extracts are used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Currently, there are two types of licensed allergen extracts:

  • Injectable allergen extracts are used for both diagnosis and treatment and are sterile liquids that are manufactured from natural substances (such as molds, pollens, insects, insect venoms, and animal hair) known to elicit allergic reactions in susceptible individuals. Injectable allergen extracts for food allergies are used only for diagnostic purposes. Among the injectable allergen extracts, some are standardized; for these products there is an established method to determine the potency (or strength) of the product on a lot-by-lot basis. For the other injectable allergen extracts there is no measure of potency, and these are called "non-standardized."
  • Sublingual allergen extract tablets are used for treatment only and are also derived from natural substances known to elicit allergic reactions in susceptible individuals, and are intended for the treatment of allergic rhinitis with or without allergic conjunctivitis.

Allergen Patch Tests

Allergen patch tests are diagnostic tests applied to the surface of the skin. Patch tests are used by healthcare providers to determine the specific cause of contact dermatitis, and are manufactured from natural substances or chemicals (such as nickel, rubber, and fragrance mixes) that are known to cause contact dermatitis.

Antigen Skin Tests

Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.

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Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

(800) 835-4709
(240) 402-8010

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Food and Drug Administration
Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave

Silver Spring, MD 20993
United States


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