Food Allergy News and Research

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.

The U.S. Food and Drug Administration today took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3 milligram products marketed by Mylan by four months beyond the labeled expiration date.

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, 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,

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.

[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.

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.

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...

As more children are diagnosed with food allergies, we hear more stories of food allergy bullying. One way to prevent food allergy bullying is to help people have a better understanding of food allergies.

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...

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).

Earlier this year, Sony Pictures Entertainment released the movie "Peter Rabbit." In the movie, a character with a food allergy is intentionally targeted. Other characters attack him with the food he is allergic to which causes anaphylaxis.