Vaccines, Blood & Biologics

Injectable Allergen Extracts- Standardized

Allergen extracts are currently manufactured in two forms: standardized and non-standardized. For the standardized allergen extracts, manufacturers compare the allergen extract to a U.S. reference standard for potency.  CBER maintains these reference standards and distributes them to manufacturers. There are currently 19 standardized allergenic extracts.

Extracts for which there are no U.S. reference standards are called non-standardized extracts.

Standardized Allergen Extracts Licensed for Distribution in the United States

Standardized Epidermals
Cat Hair (Felis domesticus)

  • ALK - Abello A/S
  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Cat Pelt (Felis domesticus)

  • ALK-Abello, Inc.
  • Jubilant HollisterStier LLC

Standardized Insects
Mite D.f. (Dermatophagoides farinae)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Mite D.p. (Dermatophagoides pteronyssinus)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Standardized Pollens
Bermuda Grass (Cynodon dactylon)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Kentucky (June) Bluegrass (Poa pratensis)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Meadow Fescue Grass (Festuca elatior)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Orchard Grass (Dactylis glomerata)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Redtop Grass (Agrostis alba)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Perennial Ryegrass (Lolium perenne)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Sweet Vernal Grass (Anthoxanthum odoratum)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Timothy Grass (Phleum pretense)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Short Ragweed (Ambrosia artemisiifolia)

  • ALK-Abello, Inc.
  • Allergy Laboratories, Inc.
  • Allermed Laboratories, Inc.
  • Antigen Laboratories, Inc.
  • Greer Laboratories, Inc.
  • Jubilant HollisterStier LLC

Standardized Venom or Venom Protein
Honey Bee Venom (Apis mellifera)

  • ALK - Abello A/S
  • Jubilant HollisterStier LLC

Wasp Venom Protein (Polistes spp)

  • ALK - Abello A/S
  • Jubilant HollisterStier LLC

White Faced Hornet Venom Protein (Dolichovespula maculate)

  • ALK - Abello A/S
  • Jubilant HollisterStier LLC

Yellow Hornet Venom Protein (Dolichovespula arenaria)

  • ALK - Abello A/S
  • Jubilant HollisterStier LLC

Yellow Jacket Venom Protein (Vespula spp)

  • ALK - Abello A/S
  • Jubilant HollisterStier LLC

Mixed Vespid Venom Protein (mixed yellow jacket, yellow hornet, and white faced hornet)

  • ALK - Abello A/S
  • Jubilant HollisterStier LLC

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 04/03/2014
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