This week the FDA approved a first-in-class switch for an antihistamine nasal spray, a new oral contraceptive, and Pradaxa was approved to prevent venous thromboembolism in pediatric patients. Also, we look at a published report on the real-world efficacy of the COVID-19 treatment remdesivir.
The FDA has approved a prescription to over-the-counter (OTC) switch for Astepro® Allergy (azelastine hydrochloride nasal spray, 0.15%).
Both treatment options were found to be effective for adults with allergic rhinitis or rhinoconjunctivitis.
After removal of the warning, cephalosporin use increased from 17.9% to 27.0% at the intervention site.
In this week’s pod, the FDA review the Emergency Use Authorization for bamlanivimab; Issues are identified at a Janssen manufacturing facility; Merck halts trials for investigational COVID therapy; A novel contraceptive is approved; And Ragwitek has its approval expanded.
The patient developed a generalized maculopapular rash approximately 3 hours after receiving warfarin.
The approval was based on data from a phase 3 trial that assessed Ragwitek in 1022 patients 5 to 17 years of age with a history of ragweed-induced rhinoconjunctivitis and sensitivity to short ragweed.
Xolair, an anti-immunoglobulin E antibody, is indicated for the treatment of moderate to severe persistent asthma, chronic idiopathic urticaria, and nasal polyps.
Evidence suggests that most patients with penicillin allergy history could safely receive cefazolin for surgical prophylaxis
The bioelectronic device was previously approved for treating sinus pain due to allergic rhinitis.
