Unlike other generic approvals, epinephrine auto-injectors are considered "combination products" because they consist of both a drug and a device, making the approval process more challenging.
In May, the Food and Drug Administration posted a drug shortage alert, adding Mylan's EpiPen (epinephrine injection) to the drug shortage list.
The FDA designation was supported by data from 7 studies evaluating the safety and efficacy of Xolair against various food allergens (eg, peanut, milk, egg, others).
Gottlieb said "The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these [drug] shortages."
Most adults (52%) reported that an EAI was not used during their most severe reaction, even though it would have been beneficial, 45% said they didn't have it with them at the time.
The pharmacokinetics trial, which included 60 participants with seasonal allergies, also demonstrated rapid drug absorption with the intranasal spray.
Intermittent supply constraints due to manufacturing delays from Mylan's manufacturing partner, Meridian Medical Technologies, have resulted in varying supply levels.
The supplemental New Drug Application (sNDA) for the 0.1mg strength was granted Priority Review by the Food and Drug Administration (FDA).
Inpatient and observation unit admissions for pediatric anaphylaxis decreased by more than half following implementation of a revised clinical care pathway.
In this case, a 55-year-old woman developed wheezing, dyspnea, and sudden loss of consciousness during her apitherapy session in which she received live bee stings to improve muscular contractures and stress.
The study enrolled 34 adolescents aged 12 to 17 years old who had no familiarity with an epinephrine device (naive) and did not receive training during the study.
With regard to adverse events, 12.4% of AR101-treated patients discontinued treatment due to treatment-related side effects; these included gastrointestinal adverse events (6.7%) and systemic allergic hypersensitivity reactions (2.7%).
Auvi-Q 0.1mg is the first epinephrine auto-injector specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds.
Most products were accurate to their stated label, however most products did contain at least 1 unspecified antigen, for instance, "brand of nut-free cookies contained gluten, whereas a gluten-free brand contained a peanut allergen," the authors write.
Results found that 4 children initially treated with PPOIT and 6 treated with placebo had allergic reactions to peanut intake, none experience prophylaxis.
In March and May 2017, two patients given intravenous (IV) infusions of curcumin emulsion compounded with polyethylene glycol (PEG) 40 castor oil reported having immediate hypersensitivity reactions.
The company has indicated that if the new auto-injector is approved they expect it to be available for patients in the first half of 2018.
The researchers found that based on very low certainty in the body of evidence across examined studies, vitamin D supplementation may not reduce the risk of developing allergic diseases.
Symjepi should only be injected into the anterolateral aspect of the thigh; injection into other areas such as the buttocks or the hands and feet may result in adverse effects and may also not provide effective treatment of anaphylaxis.
States in the Midwest and South appear to have the highest prevalence of both alpha-gal allergy and rickettsial diseases transmitted by the Lone Star tick or Amblyomma americanum.
The recall affects both the EpiPen Auto-Injector 0.15mg and 0.3mg strengths and the product was distributed by Mylan Specialty between December 2015 and July 2016.
The patient, a 33-year old woman with a history of drug hypersensitivity to NSAIDs and aspirin, presented for management of her chronic UC with mesalamine.