In an effort to better alert the public of unlawful ingredients in dietary supplements, the FDA has created the Dietary Supplement Ingredient Advisory List.
All articles by Diana Ernst
The FDA is cracking down on companies that manufacture and distribute nicotine-containing e-liquids with labeling that appears to imitate that of prescription cough syrups.
A recent report published in the American Journal of Case Reports describes a rare case of drug reaction with eosinophilia and systemic symptoms (DRESS)-induced agranulocytosis in a patient treated with the beta-lactam antibiotic oxacillin.
The Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab; Genentech), in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer.
Elderberry supplementation may reduce the duration and severity of upper respiratory symptoms.
The FDA has approved Dupixant to treat moderate-to-severe atopic dermatitis in adolescent patients.
Certain intranasal corticosteroids may place patients with allergic rhinitis at a higher risk for epistaxis.
Wixela Inhub has been made available by Mylan for the treatment of asthma and COPD.
Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline.
Phase 3 studies investigating safety, tolerability, and immunogenicity in both adults and children are currently underway.
The procedure, known as Elevoplasty, was investigated in the S.I.L.E.N.C.E. study (Snoring Intervention via Elevoplasty in a Non-surgical Clinical Environment) which included 52 patients.
The approval was based on data from the Td537 study which included individuals 18-64 years old who had received a dose of Adacel 8-12 years prior (N=1330).
According to the Company, a Phase 1 placebo-controlled, dose-escalation study of BXCL501 is expected to enroll up to 60 healthy adults across various dosing groups; pharmacokinetics and safety will be evaluated as primary endpoints.
Reports of serious adverse events related to dietary supplements containing the unapproved opioid-like antidepressant tianeptine have prompted FDA warnings.
Pimodivir was found to be beneficial in the treatment of acute uncomplicated influenza A virus infection in adult patients.
The FDA has approved the use of Oralair for the treatment of grass pollen-induced allergic rhinitis in pediatric patients aged 5-9.
The FDA has issued a safety communication alerting patients and healthcare providers that for some EpiPen and EpiPen Jr auto-injectors, and their authorized generics, the device label may become stuck to the inside of the carrier tube and potentially delay administration.
To investigate the association between this commonly used antihypertensive class and lung cancer, researchers conducted a population based cohort study involving 992,061 patients from the United Kingdom Clinical Practice Research Datalink.
To better understand the influence of prior-season vaccination on subsequent influenza vaccine effectiveness, researchers conducted a multiseason, test-negative case-control study among vaccinated children 2-17 years old recruited during 3 influenza seasons (2013-2014, 2014-2015, and 2015-2016).
The FDA has approved the use of Afluria and Afluria Quadrivalent for use in patients ≥6 months old.
“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” said FDA Commissioner Scott Gottlieb, MD.
In both studies, at 24 weeks, patients treated with dupilumab plus corticosteroid nasal spray experienced a 51% and 57% improvement in nasal congestion/obstruction severity vs 15% and 19% improvement with nasal spray alone.
The FDA has approved updated labeling for Stiolto Respimat to include COPD exacerbation data and a revised indication.
The FDA has approved Nuzyra for the treatment of adult patients with CABP and acute bacterial skin and skin structure infections.
Arikayce is intended for oral inhalation use and is administered via the Lamira Nebulizer System only.
The PFS formulation eliminates the need to reconstitute the solution before administration.
The approval was based on data from the ARCHER 1050 open-label, active controlled study which randomized patients with unresectable, metastatic NSCLC to treatment with either dacomitinib (N=227) or gefitinib (N=225).
Currently, 3 anti-interleukin (IL)5 pathway-directed treatments (benralizumab, mepolizumab, reslizumab) have been approved by the Food and Drug Administration for the treatment of severe asthma with an eosinophilic phenotype.
In general, routine annual vaccination is recommended for all patients ≥6 months of age who have no contraindications.
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.
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