What You Need to Know About the Newly Approved Generic Asthma Inhaler
The U.S. Food and Drug Administration (FDA) has approved the first generic version of an asthma inhaler, Advair Diskus. The generic inhaler is referred to as the Wixela Inhub. In addition to asthma, the inhaler is also used for patients with chronic obstructive pulmonary disease (COPD). The FDA has made this approval as part of its efforts to increase access to inhalers for those who need them and to reduce the costs of those inhalers in the hopes that more patients who need the inhalers will purchase them and use them before their conditions get worse.
The inhaler comes with some side effects, which differ for asthma and COPD patients. All patients using the inhaler may experience hoarseness, respiratory infections, and headaches. However, asthma patients using the inhaler are more likely to experience oral thrush, bronchitis, throat swelling, cough, nausea, or vomiting, while those with COPD are more likely to experience musculoskeletal pain or pneumonia as a result of the inhaler.
The new generic inhaler comes in 3 different strengths:
- Fluticasone propionate 100 mcg/salmeterol 50 mcg
- Fluticasone propionate 250 mcg/salmeterol 50 mcg
- Fluticasone propionate 500 mcg/salmeterol 50 mcg
The inhaler is meant to be used two times each day to treat asthma patients who are at least 4 years old and as a maintenance treatment for COPD patients to reduce COPD exacerbations. Unlike some other inhalers, Wixela Inhub is not meant to be used to relieve acute asthma attacks.
As part of their research and development efforts, Mylan, the company that has produced the generic inhaler, did a 28-day study with over 1,000 asthma patients to compare the effects of the 100 mcg/50 mcg Advair Diskus inhaler with those of the 100 mcg/50 mcg Wixela Inhub inhaler. Through this study, which was randomized, double-blind, and placebo-controlled, the researchers found that the treatments were equally effective and that both inhalers were well-tolerated.