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.
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...
On June 11, 2019, in Oakland, California, the Institute for Clinical and Economic Review (ICER) and its California Technology Assessment Forum (CTAF) met to assess the clinical effectiveness and value of treatments for peanut allergy. The review examined two new technologies to induce immune tolerance — Viaskin® Peanut (DBV Technologies) and AR101 (Aimmune Therapeutics) — as well as non-commercialized oral immunotherapy (OIT).
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.
The Asthma and Allergy Foundation of America (AAFA) addresses concerns regarding the Final Evidence Report assessing the clinical effectiveness and value of treatments for peanut allergy released by the Institute for Clinical and Economic Review (ICER) on July 10, 2019. ICER’s report may cause concern for the allergy community that the findings will restrict access to new treatments for peanut allergy.
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.
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...
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for inadequately controlled chronic rhinosinusis with nasal polyps.
The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
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.
The U.S. Food and Drug Administration today approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.
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 U.S. Food and Drug Administration today approved the first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older.
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.
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.
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...
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids.
The U.S. Food and Drug Administration today announced that it is requiring a boxed warning – the agency’s most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever).
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.
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...
@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...
I contacted my insurance company, Tufts, very happy that finally there is a generic Advair cost includes a $400 deductible per year then each discus is about $150. Not surprisingly, they told me that the generic isn't available on my plan. Ya. And if I wanted to, I could ask for an exception so that it's avaiable on my plan. Then, if it's approved it's TIER FIVE. The brand name Advair is tier four. So Tufts would charge me even more for the generic, IF they approved it for my plan. I've...
Sadaya, thanks for letting us know this information. You were smart to check with your insurance company and see if and how they would cover the generic version. Are you eligible for any of the programs on AAFA's patient assistance page ?
Also, could you check with your doctor and let your doctor know that, due to cost, you are not able to take your medications as directed? Your doctor may be able to help you figure out alternative medications. AAFA has a great blog post series on complementary medicine. The first blog post in the series is called: AAFA Explains: What Is the Difference Between Alternative and Complementary Medicine?
Wonderful surprise, scientist finally created a cost efficient. Generic version of my, medicine. Since Advair arrived on the, shelves my doctor has prescribed it. Since girlhood, I had to take several inhalers, pulmonary machine plus allergy medicines. So grateful about this update!
Thank you, I took Singulair for over a year in which it seemed to work great for allergies and then started having a worsening if symptoms, and developed churg-strauss syndrome. I always warn people about that med-disease connection as it is being correlated although causation has not bern proven. I have heard from others about these neuropsychiatric events. I wouldnt let my child take this med or recommend it to anyone I know due to my personal history and from these new warnings.
On May 22, 2020, the Food and Drug Administration (FDA) relaxed labeling guidelines for food companies . This is a temporary measure because of food supply issues due to COVID-19 (the new coronavirus). The Asthma and Allergy Foundation of America (AAFA) met with the FDA to talk about how this will affect the food allergy community. After the meeting, we organized a joint letter with other food allergy advocacy organizations to send to the FDA. The letter addresses the FDA’s short-term food...
The U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic medicine approved for this patient population.
KMC, My CSS was diagnosed after a medical crisis-- It was evening and I was struggling to breathe (not long after my ex dropped a bunch of my stuff that was covered in cat and dog dander off to the room I was staying in at my parents house) and I had moved out of his house because of my severe allergies (which seemed controlled with Singualair at first that is why I moved in there but after a year I had asthma symptoms and phlegm and kept needing to go to the ER for breathing treatments and...
Novartis today announced that the US Food and Drug Administration (FDA) approved the supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved US indications.1 Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.
If you are currently on Xolair or considering it, what are your thoughts about self injections? Excited that this will make things more convenient? Apprehensive about doing the shots at home instead of a clinic? Join the discussion !
I've been on Xolair injections for 8 months now, and we're doubling my dose since my IgE levels are still very high. Even though the FDA has approved injecting at home, my physician's office is still apprehensive about allowing me to inject at home. I have Epi pens and I'm ready to make the switch. It will save me an hour round trip, and $65 per injection. Is it typical for doctor's offices to be nervous about switching?
Amgen today announced its partner AstraZeneca submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma.
The U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six years of age and older.
As regulators, the FDA recognizes they have an important task ahead of them that will require them to act expeditiously while undertaking an extremely meticulous and thoughtful review once we receive requests to authorize a COVID-19 vaccine for emergency use or submissions for approval of a COVID-19 vaccine for this population.
Update for Oct. 4, 2021: Did you miss the live stream of the PFDD meeting on food allergy? You can watch the recording . You can still share your experiences living with and managing food allergy. Send in your comments by Oct. 9, 2021. We will include your comments in the upcoming food allergy “Voice of the Patient Report.” We will send this report to FDA representatives. By sharing your story, you can help influence the future of treatments for food allergies. SUBMIT YOUR COMMENTS The...
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