First Advair Diskus Generic Approval Announced by FDA

Last updated: February 2019

On Wednesday January 30th, 2019, the United States Food and Drug Administration (FDA) announced that they have approved a generic alternative to the medication Advair Diskus (fluticasone propionate and salmeterol inhalation powder).1 Advair Diskus is approved for use in patients four years of age and older and is an important maintenance medication for patients with asthma and chronic obstructive pulmonary disease (COPD).1 Used twice daily, Advair Diskus is used to reduce the number of asthma attacks and COPD exacerbations, and can reduce the use of rescue inhalers.1

While regular use of Advair Diskus can be incredibly beneficial for those with asthma and COPD, it is a brand name medication, which can result in higher costs and copays for both patients and their insurance companies. A generic version of this medication may make the drug more accessible to asthma and COPD patients who couldn’t afford the medication in the past.2 The FDA states that over 26 million people (many millions of which are children) in the United States have an asthma diagnosis, and as many as 16 million people in the United States are living with COPD.1 A less expensive generic brings competition to the market, which usually benefits patients overall.2

While quite a few companies have proposed a generic version of Advair Diskus, the FDA has rejected all these attempts in the recent past.3 The biggest challenge for manufacturers has been meeting FDA standards in creating both a high quality generic for a combination medication (Advair Diskus is made of two combined medications, fluticasone propionate and salmeterol) and the inhalation device that makes the drug powder able to be inhaled. Both the generic drug and the device must go through rigorous testing to prove that they meet the same standards of safety and quality as their brand name counterparts.1 They must also prove that they meet the same manufacturing quality requirements as well.

Fluticasone propionate and salmeterol inhalation powder will come in 3 strengths: 100mg/50mg, 250 mg/50 mg and 500 mg/50mg, the same as the current brand name product.1 There was no indication of when the generic medication would arrive in pharmacies, but you should talk with your health care team, including your local pharmacist or pharmacy technician, about when they expect they will receive the medication. Your pharmacist should be able to substitute the generic medication as soon as it is available, but pharmacy laws vary from state to state, so ask your doctor or pharmacist if you will need a new prescription to get the generic medication when it is available.

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