Five recent FDA approvals and actions involving allergy, asthma

Recent FDA actions have included the approval of fluticasone propionate 50 mcg spray for over-the-counter treatment of hay fever and upper respiratory allergy symptoms, as well as the acceptance of a new drug application for an albuterol multi-dose breath-actuated dry-powder inhaler.

Here are highlights of FDA news presented in Healio Allergy/Immunology:

1. Flonase approved for OTC allergy treatment

GlaxoSmithKline announced that the FDA approved its fluticasone propionate 50 mcg spray for over-the-counter treatment of hay fever and upper respiratory allergy symptoms.

Flonase Allergy Relief nasal spray will be available at full prescription strength to provide 24-hour non-drowsy allergy relief beginning early in 2015, according to the release. Fluticasone propionate was approved as a prescription medication in 1994. Read more

2. Striverdi Respimat approved for COPD, includes asthma warning

The FDA announced approval of olodaterol inhalation spray to treat patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, who experience airflow obstruction.

Olodaterol (Striverdi Respimat, Boehringer Ingelheim Pharmaceuticals) is a long-acting beta-adrenergic agonist (LABA) that allows muscles around the lungs’ airways to stay relaxed to prevent symptoms and can be used daily for an extended period. LABAs increase the risk for asthma-related deaths, according to Striverdi Respimat’s boxed warning. Read more

3. FDA accepts NDA for breath-actuated dry-powder inhaler

The FDA has accepted Teva Pharmaceutical Industries’ new drug application for its albuterol multi-dose dry-powder inhaler.

The breath-actuated dry-powder inhaler is being investigated for the treatment or prevention of bronchospasm in patients aged 12 years or older who have reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm in patients aged 12 years or older, according to a press release from Teva. Read more

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4. Warning of allergic reactions to lupin posted online

The FDA posted information warning of allergic reactions to lupin, a legume belonging to the same plant family as peanuts, on its Consumer Updates webpage.

Anaphylaxis has been reported, the update said, and reactions include hives, swelling of the lips, vomiting and breathing difficulties. Lupin is used frequently in gluten-free products as a substitute for gluten-containing flours, and people allergic to peanuts appear to have a greater chance of having a lupin allergy. Read more

5. GSK's Arnuity Ellipta approved for treating asthma

The FDA approved fluticasone furoate inhalation powder as a once-daily corticosteroid for maintenance treatment of asthma in patients aged 12 and older, according to a press release.

Fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) is approved for 100 mcg and 200 mcg doses, according to the release. Read more