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Tagged With "Food and Drug Administration"

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3 New Studies Shed Light on Penicillin Allergy

AAFA Community Services ·
At some point you may have had a reaction to penicillin and were told you were allergic. And there’s a good chance it has stayed in your chart throughout your childhood and into adulthood. But 9 of 10 Americans who think they have a penicillin allergy have either outgrown it or never had it in the first place. That said, it’s important to get tested by an allergist to know if you have a true penicillin allergy so you know whether to avoid the drug.
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3 Ways to Keep Spring Celebrations Asthma and Allergy Friendly

AAFA Community Services ·
3 Ways to Keep Spring Celebrations Asthma and Allergy Friendly
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7 Things You Should Know About Oral Allergy Syndrome

AAFA Community Services ·
Did you know pollen might be responsible for your food allergy? If your mouth or throat itch when you eat certain fruit or vegetables, you could have oral allergy syndrome (OAS). And you would have a pollen allergy to thank for that.
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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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AAFA Applauds Senators Grassley and Wyden for Drug Pricing Hearings

AAFA Community Services ·
On behalf of the more than 60 million Americans with asthma and allergies – many of whom depend on life-saving medications – the Asthma and Allergy Foundation of America (AAFA) applauds Senators Chuck Grassley and Ron Wyden for holding hearings on drug pricing in America. This series of hearings demonstrates the senators’ commitment to exploring the problem of overpriced medications in America.
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AAFA Applauds Walgreens and Kaléo Partnership, Increasing Patient Access to Life-Saving Epinephrine

AAFA Community Services ·
Walgreens and kaléo, a privately-held pharmaceutical company, are working together to improve access to epinephrine auto-injectors by making kaléo’s AUVI-Q® available through Walgreens locations nationwide. The Asthma and Allergy Foundation of America (AAFA) applauds this 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.
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AAFA CEO Shares Patient Concerns About Restrictions to Allergen Immunotherapy

AAFA Community Services ·
AAFA does not support the changes proposed by USP because we believe they pose a real threat to quality of care. We strongly urge the USP to keep existing guidelines for allergen immunotherapy in place so that millions of patients across the United States can continue to receive the treatment they need.
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AAFA Co-Sponsored Report Provides Recommendations for Food Allergy Research, Treatment, and Policy

AAFA Community Services ·
[Press Release] PR Contact: Adam Bailine, Vice President, Marketing & Communications (202) 466-7643, ext. 254 abailine@aafa.org AAFA Co-Sponsored Report Provides Recommendations for Food Allergy Research, Treatment, and Policy With support from the Asthma and Allergy Foundation of America (AAFA), the National Academies of Sciences, Engineering, and Medicine releases a monumental report that makes recommendations to increase our understanding of and approaches to food allergies November...
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AAFA Elevates Patient Voice in ICER Review of New Peanut Allergy Treatments

AAFA Community Services ·
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).
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AAFA Explains: Can Herbal Supplements Help My Nasal Allergies?

AAFA Community Services ·
When new drugs and medical procedures are developed, they go through rigorous scientific study. Complementary Alternative Medicine treatments usually do not go through the same type of research. As a result, whether it works (called efficacy) is unproven for most treatments. Most herbal remedies for rhinitis fall into that category.
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AAFA Explains: Will Coffee or Caffeinated Drinks Help My Asthma?

AAFA Community Services ·
This post discusses claims that caffeine can be used to treat asthma symptoms. It is part of our “ AAFA Explains ” series looking at complementary and alternative medicine (CAM) aimed at asthma and allergies. The Asthma and Allergy Foundation of America (AAFA) wants to guide you as you decide between choices that may be “likely safe” or “potentially unsafe.” What is asthma? Asthma is a chronic disease that causes your airways to become inflamed, making it hard to breathe. There is no cure...
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AAFA Issues Parental Guidance Warning About New Peter Rabbit Film

AAFA Community Services ·
The Asthma and Allergy Foundation of America (AAFA) cautions parents raising children with food allergies that some scenes in the newly-released “Peter Rabbit” film may be disturbing for young viewers with food allergies. In the film, a character with a known food allergy to blackberries is attacked with them. This leads to a severe allergic reaction known as anaphylaxis and the need to use a lifesaving injection of the drug epinephrine.
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AAFA Joins 96 Other Patient Groups to Oppose Rule That Would Harm People With Chronic Conditions

AAFA Community Services ·
The I Am Essential coalition, submitted comments, signed by 97 patient groups, to the U.S. Department of Health and Human Services in opposition to the Trump Administration's proposed rule that would expand the scope and applicability of short-term, limited-duration insurance plans (short-term plans). The rule, if finalized, would have a crippling effect on individuals' healthcare.
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AAFA Joins Other Patient Groups to Voice Concerns Over Health Care Ruling

AAFA Community Services ·
Access to proper health care coverage is essential and life-saving for people with asthma and allergies. The Asthma and Allergy Foundation of America has joined other patient groups to make up the I Am Essential coalition to advocate against changes that could threaten health care coverage for those we serve. This press release outlines the coalition's concerns about these proposed changes.
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Plea to the Department of Health and Human Services: People With Allergies Need Access to Epinephrine Now

AAFA Community Services ·
Manufacturing and insurance issues have made it hard for many members of our community to fill their prescriptions for epinephrine auto-injectors in recent months. But the drug epinephrine itself is not in short supply. This has become a serious concern for families of children with life-threatening food allergies. When families who manage food allergies are in fear for their children's lives because they can't get the medicine they need, our system is broken.
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AAFA Tackles Childhood Asthma and Allergies

AAFA Community Services ·
Asthma and allergies impact one in five children in the United States. The Asthma and Allergy Foundation of America (AAFA) exhibited at the 2019 American Academy of Pediatrics (AAP) conference to learn the latest news in pediatrics and to talk to health care providers about the programs and services we offer.
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AAFA Urges Inclusion of Patient Voice in Analysis of Costly New Asthma Drugs

AAFA Community Services ·
Biologics are a new class of drugs that fight disease at the source . Instead of attacking symptoms, these drugs target diseases like asthma at a molecular level. These newer types of drugs are more expensive than older medicines. That is prompting public discussion on how to pay for them. The cost of caring for patients with the most severe forms of asthma represents a majority of asthma healthcare spending. In addition, asthma is a leading cause of missed time from work and school. Last...
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Advances in Asthma and Allergies in 2019

AAFA Community Services ·
These are just a few things we were able to do this year for the asthma and allergy community because of you. But there is more for us to do to significantly reduce the burden of these diseases on people with asthma and allergies. And we can with your help.
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Aerospan Inhaler for Daily Asthma Maintenance Is Being Discontinued

AAFA Community Services ·
According to the Food and Drug Administration (FDA), Mylan is discontinuing Aerospan® (80 mcg). Aerospan is a corticosteroid inhaler used for daily asthma maintenance. Mylan notified the FDA on Jan. 26, 2018.
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Albuterol Inhaler Shortage Due to COVID-19 Could Impact People With Asthma

AAFA Community Services ·
The Asthma and Allergy Foundation of America is sharing this message from the American College of Allergy, Asthma and Immunology (ACAAI)for people with asthma about a shortage of albuterol metered dose inhalers
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Alert: FDA Requests Removal of All Ranitidine Products (Zantac) From the Market

AAFA Community Services ·
The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperature
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Asthma and Allergy Caucus to FDA: Take Action to Prevent Albuterol Shortages

AAFA Community Services ·
Congressmen Eliot L. Engel (D-NY) and Fred Upton (R-MI), Co-Chairs of the Asthma and Allergy Caucus, joined by Congressmen TJ Cox (D-CA) and Peter King (R-NY), Members of Caucus, led 57 Members of the House on a letter to the Food and Drug Administration (FDA) about shortages of albuterol inhalers, which are critical to effective asthma management.
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Asthma and Allergy Foundation of America Responds to Premature ICER Review of New Peanut Allergy Treatments

AAFA Community Services ·
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.
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AAFA Explains: Can Essential Oils Help Asthma?

AAFA Community Services ·
Essential oils, like herbal remedies, come from plants. Practitioners of traditional and folk medicine (usually meaning those without a medical degree) have used essential oils for thousands of years, much like herbal remedies. Is there any evidence to back up claims that essential oils can help my asthma?
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Asthma Drug Shortages During COVID-19: A Letter From AAFA’s President and CEO

AAFA Community Services ·
Because of the COVID-19 (new coronavirus) pandemic, we are facing a challenging and unprecedented time. COVID-19 is a respiratory infection, and the nearly 25 million Americans with asthma are at high risk for complications from the virus. As the leading patient organization for people with asthma and allergies, this has the Asthma and Allergy Foundation of America (AAFA) deeply concerned for your health and well-being.
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Avoid Food Allergy Reactions During the Holidays

AAFA Community Services ·
During the holiday season, our calendars fill up with a lot of social activities. More often than not, these include food. If you or a member of your family has a food allergy, these events can be more stressful than fun. Follow these tips to keep everyone safe from accidental allergic reactions.
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Breathing in the Boat: The Turnaround Point

Megan Roberts ·
By Megan Roberts, Community Engagement Program Manager at the Asthma and Allergy Foundation of America This post is a follow up to Breathing in the Boat: Dragon Boat World Championships With Asthma . Paddling is my passion. I’ve raced boats in half of the world’s oceans, Hungary, Italy, Hawaii, Canada, Puerto Rico and all over the United States. I have not, however, ever had the opportunity before 2017 to race in China, the birthplace of the sport of dragon boating more than 2,500 years ago.
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Congress Recognizes May as National Asthma and Allergy Awareness Month

AAFA Community Services ·
The U.S. House of Representatives has declared their support for National Asthma and Allergy Awareness Month . Reps. Eliot Engel (D-NY), Fred Upton (R-MI), TJ Cox (D-CA) and Peter King (R-NY) submitted the resolution to the House Committee on Energy and Commerce on May 8, 2020. May is peak season for people with asthma and allergies. That’s why the Asthma and Allergy Foundation of America (AAFA) chose it as a time to raise awareness and educate people on how to manage these conditions. Read...
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Could Drones Save Lives by Responding to Asthma and Allergy Emergencies?

AAFA Community Services ·
Could drones be used someday to deliver life-saving medications or interventions in the case of a child’s emergency, a drug overdose or in response to a mass casualty scene? According to new research presented at the American Academy of Pediatrics 2019 National Conference & Exhibition, it’s an idea worth exploring.
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COVID-19 and Its Impact on People With Asthma and Allergies: A Global Health Crisis

AAFA Community Services ·
The Asthma and Allergy Foundation of America (AAFA) has been fighting to save lives for nearly 70 years. With your support, we provide education, conduct patient-centered research and advocate for protections for our community. Our experience and strong community ties allowed us to take prompt action on the COVID-19 crisis . Thanks to your generous support, we are leading the fight against COVID-19 for people with asthma and allergies. But we need your help to continue to provide COVID-19...
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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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Donate Allergy-Friendly Food to Those Affected by Hurricane Harvey

AAFA Community Services ·
Many of our members in Houston, and the surrounding areas of Texas and into Louisiana, continue to be affected by Hurricane Harvey and the ensuing flooding. If you are in the affected area and want to help, we have listed the name of an agency who is accepting allergy-friendly food donations, with delivery instructions so the food can make it safely to those who need it.
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Dupilumab Shows Benefit for Those With Severe Asthma During Clinical Trial

AAFA Community Services ·
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Phase 3 investigational study evaluating dupilumab in adults and adolescents with severe, steroid-dependent asthma met its primary endpoint and key secondary endpoints.
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Dupixent® Shows Positive Results in Phase 3 of Trial for Ages 6 to 11 With Severe Atopic Dermatitis

AAFA Community Services ·
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) to treat severe atopic dermatitis in children aged 6 to 11 years met its primary and secondary endpoints. Dupixent is the first and only biologic to show positive results in this pediatric atopic dermatitis population.
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Facebook Chat: School Accommodations for Food Allergies and Asthma

AAFA Community Services ·
Join the Asthma and Allergy Foundation of America and Kids With Food Allergies for a back-to-school Facebook chat. Attorney, author and food allergy advocate Laurel Francoeur, Esq., will answer your questions on how to send your child with asthma and food allergies back to school with the right accommodations to keep them safe.
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FDA Approves a New Treatment Option for Those With Severe Asthma

AAFA Community Services ·
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
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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 Dupixent® for Treatment of Asthma

AAFA Community Services ·
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.
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FDA Approves Dupixent® for Chronic Rhinosinusitis With Nasal Polyps

AAFA Community Services ·
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.
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FDA Approves Dupixent® for Moderate-to-Severe Atopic Dermatitis in Adolescents

AAFA Community Services ·
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
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FDA Approves FASENRA® Pre-Filled Auto-Injector Pen for Self-Administration

AAFA Community Services ·
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the self-administration of FASENRA® (benralizumab) in a pre-filled, single-use auto-injector (the FASENRA Pen™).
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FDA Approves First Generic ADVAIR DISKUS® for Asthma Treatment

AAFA Community Services ·
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).
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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 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 Approves Generic of Proventil HFA Albuterol Inhaler to Meet Demand Due to COVID-19

AAFA Community Services ·
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.
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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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FDA Approves ProAir HFA Generic, a Quick-Relief Medicine for Asthma

AAFA Community Services ·
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.
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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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FDA Approves Spiriva Respimat to Treat Asthma In Children Ages 6-12

AAFA Community Services ·
[Press Release] FDA Expands Approval of SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children Steroid-free SPIRIVA RESPIMAT now approved as asthma treatment for age 6 and older Supplemental New Drug Application (sNDA) approved under priority review from the FDA FDA also granted pediatric exclusivity to SPIRIVA RIDGEFIELD, Conn., Feb. 16, 2017 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and...
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FDA Approves Symbicort to Treat Asthma In Children Ages 6-12

AAFA Community Services ·
AstraZeneca announced that the US Food and Drug Administration (FDA) approved SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 micrograms for the treatment of asthma in pediatric patients aged six up to 12 years.
 
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