Tagged With "FDA"

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AAFA Brings Perspective of Asthma, Allergy Patients to FDA

AAFA Community Services ·
What is it like to have food allergies, asthma, or nasal allergies? What do patients need and want from their treatments? How can we improve allergy care? The chief executive officer of the Asthma and Allergy Foundation of America spoke about these issues at a recent FDA advisory committee meeting. Dr. Cary Sennett spoke to the Allergenic Products Committee about the everyday challenges of life with food allergies, asthma and other allergies. Dr. Sennett attended the meeting to represent...
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FDA Approves Cinqair to Treat Severe Asthma

AAFA Community Services ·
FDA News Release FDA approves Cinqair to treat severe asthma For Immediate Release March 23, 2016 Inquiries Media Andrea Fischer 301-796-0393 Consumers 888-INFO-FDA Release The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current...
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FDA Approves First Seasonal Influenza Vaccine Containing an Adjuvant

AAFA Community Services ·
The U.S. Food and Drug Administration approved Fluad, the first seasonal influenza vaccine containing an adjuvant.
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FDA Proposes Ban on Most Powdered Medical Gloves

AAFA Community Services ·
FDA News Release FDA proposes ban on most powdered medical gloves For Immediate Release March 21, 2016 Release Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling. The proposed ban...
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New Eczema Drug Dupixent Approved by FDA

AAFA Community Services ·
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
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Re: New Eczema Drug Dupixent Approved by FDA

Kathy P ·
Welcome One Woman. I don't know that it has been approved for dyshidrotic eczema, but it's worth talking to the doctor. Have you figured out any triggers that make it worse?
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Re: New Eczema Drug Dupixent Approved by FDA

OneWoman ·
I was just wondering if anyone has any knowledge or experience with Dupixent and Dyshidrotic Eczema? I have had it for almost 2 years now. I have tried everything I know to do, as well as Rx creams from my Dr., and nothing helps...not even a little. The skin on my hands (back, front, sides, all fingers- sides, top, bottom) is so thick and itches so bad all the time. The only way I can relieve the itching is by popping the blisters. I'm about to go insane. I don't know what to do. The subject...
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Re: New Eczema Drug Dupixent Approved by FDA

OneWoman ·
@Jen would you know I had an appt with her last week, and I completely spaced this med out. I did talk to her about my eczema, and she did prescribe me a steroid cream (again), but, I forgot to ask about Dupixent. Rats! Not sure when I'll be going in to see her again, either...
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Re: New Eczema Drug Dupixent Approved by FDA

Jen ·
@OneWoman What did your doctor have to say about Dupixent?
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Re: New Eczema Drug Dupixent Approved by FDA

Jen ·
Do you feel like the steroid cream is helping?
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FDA Approves Removal of Asthma-Related Death Box Warnings From Certain Asthma Medicines

AAFA Community Services ·
FDA's most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. A FDA review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone.
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CVS Sinus Relief Nasal Mist Recalled Due to Contamination

AAFA Community Services ·
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.
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FDA Approves First Generic Competitor of EpiPen Epinephrine Auto-Injector

AAFA Community Services ·
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.
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FDA Extends Expiration Dates of Certain Lots of EpiPens®

AAFA Community Services ·
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.
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What People With Asthma Need to Know About Foods Made With Liquid Nitrogen

AAFA Community Services ·
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?
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FDA Approves New Flu Treatment

AAFA Community Services ·
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.
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AAFA Applauds FDA First Steps Toward Declaring Sesame as Major Allergen

AAFA Community Services ·
The Asthma and Allergy Foundation of America (AAFA), the premiere nonprofit representing patients with asthma and allergies, applauds the recent request for information and statement from the Food and Drug Administration (FDA) demonstrating its commitment to explore the classification of sesame as a major allergen.
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Re: AAFA Applauds FDA First Steps Toward Declaring Sesame as Major Allergen

K8sMom2002 ·
Woohoo! This is great news for my friends who manage a sesame allergy!
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AAFA Issues Statement on FDA Approval of Primatene Mist for Mild Asthma

AAFA Community Services ·
People with asthma have more treatment choices than ever before, and the FDA recently announced approval for the readmittance of Primatene Mist – an over-the-counter (OTC) epinephrine inhaler. The Asthma and Allergy Foundation of America (AAFA) cautions patients to not stop their current asthma treatment nor start taking this OTC option without talking to their health care provider first.
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