This effort is in response to epinephrine auto-injector supply issues reported by manufacturers to the Food and Drug Administration (FDA).
The risk of a mixing-up the treatments is especially high for pregnant women, says the Food and Drug Administration (FDA), as losartan is indicated to treat high blood pressure and could harm or kill a fetus.
The bioavailability of the novel epinephrine nasal spray also proved similar to that of intramuscular injection with EpiPen 0.3mg injection.
ADVM-053 is being developed as a single‑administration treatment that could potentially provide sustained levels of the C1 esterase inhibitor protein, which may prevent breakthrough angioedema attacks.
The approval was based on data from 4 clinical trials, including the 26-week Phase 3 HELP (Hereditary Angioedema Long-Term Prophylaxis) study that enrolled 125 patients with HAE aged ≥12 years.
Haemophilus influenzae, Staphylococcus aureus, and Streptococcus pyogenes were found in approximately one-fifth of isolated IgE antibodies via plasmablasts residing in nasal polyps.
This date modification beyond the approved 20-month shelf life was based an FDA review of product stability data submitted by Mylan.
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).
The recalled nasal decongestant has a Lot number of 173089J and an expiration date of 09/19; it is packaged in 0.5 fluid ounce bottles.
The Company is currently conducting a Phase 3 trial (APeX-2) and a long-term safety study (APeX-S) evaluating 2 doses of the treatment.
Sensitization to Aspergillus fumigatus increased the risk for severe asthma.
An increase in atheroma burden and plaques with less stable features demonstrated an association with immunoglobulin E to α-Gal.
Respiratory symptoms were more common in older children compared with infants who presented with food-induced anaphylaxis.
In addition to respiratory sensitivity to aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), patients with AERD oftentimes experience an additional allergic reaction when drinking alcohol.
The approval was based on data from a randomized, single-blind, multicenter, dose-ranging, crossover study which evaluated the safety and efficacy of Cinryze in 12 pediatric patients (7 to 11 years old).
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.
A nasal immune-response pattern characterized by lower non-interferon antiviral immune response mediators and higher type 2 and type 17 cytokines was significantly associated with recurrent wheeze at 1 year.
The pharmacokinetics trial, which included 60 participants with seasonal allergies, also demonstrated rapid drug absorption with the intranasal spray.
Vitamin D supplementation appears to reduce the recurrent wheezing by 12 months of age in black infants born prematurely.
Researchers developed a predictive algorithm to identify individuals with a higher risk for severe reactions to the standardized peanut oral food challenge.
Fluticasone Propionate Nasal Spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older.
Montelukast improved symptoms in a significant proportion of individuals with angioedema-predominant chronic spontaneous urticaria.
The pattern of laryngeal motor dysfunction and the prevalence and severity of laryngeal hypersensitivity in individuals with chronic cough were similar to that observed in individuals with vocal cord dysfunction and muscle tension dysphonia.
Researchers have developed a novel algorithm to identify hypersensitivity pneumonitis.
Nasal beclomethasone dipropionate was more effective in improving nasal patency and cytology as well as quality of life compared with cetirizine in children with perennial allergic rhinitis.
Potential risk factors for eosinophilic esophagitis include antibiotic use in infancy and behaviors such as smoking and alcohol intake.
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).