Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions For Immediate Release November 7, 2018 Contact Consumers Recall Department firstname.lastname@example.org Announcement Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be...
FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.
Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
The FDA has approved another biologic treatment, Dupixent, for the treatment of both moderate and severe asthma patients with eosinophilic phenotype and oral corticosteroid-dependent asthma, regardless of phenotype.
The Asthma and Allergy Foundation of America (AAFA) led a research study called Atopic Dermatitis in America . The purpose of this study is to shed light on the number of adults who deal with this frustrating skin condition. This week, AAFA has released early findings from the report. One surprising find from the study was the number of adults with AD who say it is moderate to severe. As many as 40% of the people surveyed said they had moderate-to-severe AD. Through this study, we hope to...
Ragweed and other fall allergens are found throughout the U.S., but some areas feel the effects more than others. The Asthma and Allergy Foundation of America (AAFA) has released the 2018 Fall Allergy Capitals™ report.
AstraZeneca and its partner Amgen Inc. (Amgen) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.
Circassia Pharmaceuticals, Inc., a specialty pharmaceutical company focused on respiratory disease, is pleased to announce that Aetna, one of the largest health insurance companies in the United States, has updated its Exhaled Breath Tests Clinical Policy to include the measurement of exhaled nitric oxide as “medically necessary” for the evaluation of asthma and for monitoring the response to long-term control therapy.
One recent food trend has some people concerned: adding liquid nitrogen right before eating to create the effect of smoke. It may sound fun, but is it safe, especially for people with asthma?
Walgreens and kaléo, a privately-held pharmaceutical company, are working together to improve access to epinephrine auto-injectors by making kaléo’s AUVI-Q® 0.15 mg and 0.3 mg available through Walgreens locations nationwide. This comes in an effort to help thousands of Americans with their epinephrine needs during the back to school season, as supply issues have been reported to the U.S. Food and Drug Administration (FDA) by other manufacturers.
The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.
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.
Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.
Genentech, a member of the Roche Group, today announced that the Phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study’s primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo.