Food Allergy News and Research

AAFA Applauds Walgreens and Kaléo Partnership, Increasing Patient Access to Life-Saving Epinephrine

Walgreens and kaléo, a privately-held pharmaceutical company, are working together to improve access to epinephrine auto-injectors by making kaléo’s AUVI-Q® available through Walgreens locations nationwide. The Asthma and Allergy Foundation of America (AAFA) applauds this effort to help thousands of Americans with their epinephrine needs during the back to school season, as supply issues have been reported to the U.S. Food and Drug Administration (FDA) by other manufacturers.

Walgreens Locations Will Now Carry AUVI-Q Epinephrine Auto-Injectors

Walgreens and kaléo, a privately-held pharmaceutical company, are working together to improve access to epinephrine auto-injectors by making kaléo’s AUVI-Q® 0.15 mg and 0.3 mg available through Walgreens locations nationwide. This comes in an effort to help thousands of Americans with their epinephrine needs during the back to school season, as supply issues have been reported to the U.S. Food and Drug Administration (FDA) by other manufacturers.

Epinephrine Nasal Spray Gets Fast Track Status From FDA as a Possible Treatment for Life-Threatening Food Allergy Reactions

INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s epinephrine nasal spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.

FDA Approves First Generic Competitor of EpiPen Epinephrine Auto-Injector

The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

Kaléo Confirms U.S. Availability of AUVI-Q® Auto-injector for Back-to-School Season

Kaléo, a privately-held pharmaceutical company, today commented on reports of continued manufacturing delays of epinephrine auto-injectors in the United States. Kaléo confirmed that AUVI-Q® (epinephrine injection, USP) Auto-injectors are available for prescription and are not affected by the manufacturing delays reported by other epinephrine auto-injector manufacturers. Kaléo has sufficient supply to meet any anticipated demand. For live assistance in filling an AUVI-Q prescription, any patient,

FDA Grants Breakthrough Therapy Designation for Xolair (Omalizumab) for Food Allergies

Genentech announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair® (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases, and to help ensure people have access to them through FDA approval.

Updated Mylan Statement on U.S. Supply of EpiPen Auto-Injectors

[PRESS RELEASE] Our manufacturing partner Meridian Medical Technologies, a Pfizer company, continues to experience interruptions in the production of EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors. Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies. We are actively exploring several options with Pfizer that would help stabilize supply.

We Need Your Stories About USDA Allergen Labeling

Have you had trouble reading USDA food labels for top 8 allergens (milk, egg, peanut, tree nut, wheat, soy, fish and shellfish)? The U.S. Department of Agriculture (USDA) Food and Inspection Service regulates meat, poultry, processed egg products and certain foods that contain these products. AAFA needs your story about the challenges of reading these labels to submit to the USDA to prove the need for clearer allergen labeling for the top 8 allergens.

We Need Your Story About Sesame Labeling in the U.S.

Have you had issues with undeclared sesame or sesame hiding in foods? We need your story to submit to the Food and Drug Administration (FDA) to prove the need for allergen labeling for sesame in the U.S. Send us your examples of the following to advocacy@aafa.org . Foods with undeclared sesame - these are foods where a) “sesame” is not listed in the ingredients, and b) you confirmed separately that there is sesame in the product. Food labels where sesame is listed in the ingredients under an...

What To Do If You Have Trouble Filling Your EpiPen® or Generic Epinephrine Prescription

UPDATE – What we know as of Sept. 6, 2018: ♦ Mylan, distributor of EpiPen®, issued a new statement about the status of their supplies of epinephrine auto-injectors . If you are having trouble getting your EpiPen® prescription filled, you can call Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies . Mylan has confirmed to Kids With Food Allergies that they are committed to drop shipping if there isn't an option that is close. ♦ The FDA has extended the...

Epinephrine Auto-Injectors for Infants and Toddlers to Be Available May 1

Kaléo, a privately-held pharmaceutical company, today announced that AUVI-q® (epinephrine injection, USP) 0.1 mg will be available nationwide by prescription beginning May 1, 2018. AUVI-q 0.1 mg is indicated for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and toddlers weighing 16.5 to 33 pounds (7.5 to 15 kilograms).

Kids With Food Allergies
A Division of the Asthma and Allergy Foundation of America
8201 Corporate Drive Suite 1000 Landover, MD 20785
Phone: 1-800-7-ASTHMA (1.800.727.8462)
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