FDA approves first true generic of Flovent inhaler

In this article:

• Significance
• Brand-name Flovent
• Authorized vs. true generic
• What to know
• Bottom line

In this article

• Significance
• Brand-name Flovent
• Authorized vs. true generic
• What to know
• Bottom line

The Food and Drug Administration (FDA) has approved the first true generic of Flovent HFA (fluticasone propionate), an inhaled medication used as a maintenance treatment of asthma in people ages 4 years and older. The FDA has approved the generic in the 44 mcg per actuation strength. 

Asthma affects more than 28 million people in the U.S., according to the Asthma and Allergy Foundation of America (AAFA), and inhaled corticosteroids like fluticasone propionate are considered a lifeline for many. 

That’s because inhaled corticosteroids are considered highly effective in preventing asthma exacerbations in people with persistent asthma, reducing symptoms and improving quality of life. 

Why this approval is significant

Authorized generics of this medication have been available, but the approval of this generic version of fluticasone propionate marks the first independently manufactured generic approved through the FDA’s abbreviated pathway.

That’s significant because it may ultimately result in cost savings for people who need this type of medication. True generics can drive price competition in ways that authorized generics might not. 

In the approval announcement released on March 3, the FDA noted that granting approval of fluticasone propionate inhalation aerosol to Glenmark Specialty SA will give people more options and expand access to affordable asthma treatment.

“Between 5 and 10% of Americans and just over 6% of children have an asthma diagnosis. Flovent is a highly effective preventive medication, which, when used regularly, has been linked to a reduction in asthma-related hospitalizations and admissions to intensive care. As of today, with the approval of the first generic metered dose inhaler form of the medication, we anticipate increased availability and reduced costs of treating this prevalent and at times very serious condition,” Tracy Beth Høeg, MD, Ph.D, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

What happened to brand-name Flovent

The news of the approval of the first true generic fluticasone propionate inhalation aerosol comes more than two years after manufacturer GlaxoSmithKline (GSK) announced it would stop producing the brand-name Flovent on January 1, 2024.

Until then, GSK had produced both a metered dose inhaler (Flovent HFA) and a dry powder inhaler (Flovent Diskus). When brand-name Flovent was discontinued, patients had to decide whether to switch to a different asthma medication or move to an authorized generic. 

For example, their healthcare provider may have considered other inhaled corticosteroids on the market, which include alternatives such as: 

• budesonide (Pulmicort Flexhaler, Pulmicort Respules)
• ciclesonide (Alvesco)
• beclomethasone (Qvar Redihaler)
• mometasone (Asmanex HFA, Asmanex Twisthaler)
• fluticasone furoate (Arnuity Ellipta)

According to a JAMA study, the withdrawal of brand-name Flovent from the market had negative consequences for some vulnerable patients, increasing discontinuation of medication and symptoms.

Authorized generic vs. true generic: What’s the difference?

If you didn’t realize that there’s a difference between an authorized generic and a true generic, you’re not alone. It can be confusing. 

First, it’s important to consider what they have in common. Authorized generics and true generics do contain the same active ingredient that’s in the brand-name drug, as well as the same conditions of use, dosage form, strength, and route of administration, according to the FDA. All generics have to meet the same quality and manufacturing standards as the brand-name drug, so a generic fluticasone propionate would have to meet the same standards as the name-brand Flovent. 

However, there are a few differences:

Authorized generic

• Manufactured by the same company that made the brand-name drug (or a licensed partner)
• Identical in formulation, device, and labeling, but does not carry the brand name

True generic

• Manufactured by a different company than the brand-name manufacturer.
• Approved through an abbreviated new drug application demonstrating bioequivalence to the reference product.
• Represents independent market competition rather than a relabeled brand product.

The generic, approved on March 3 by the FDA, falls into the ‘true generic’ category because it will be manufactured by Glenmark Specialty SA, not GSK, which manufactured Flovent. Meanwhile, the authorized generic version of Flovent HFA is manufactured by GSK and distributed by Prasco Laboratories. 

What this means for patients and prescribers

The arrival of a true generic version of Flovent could mean lower list prices and improved insurance coverage in the future.

Dr. Alex Courville, MD, a family medicine physician and owner of the Kinder Clinic, a community-based health center in Kinder, Louisiana, notes that the arrival of a true generic Flovent is good news. He calls the Flovent “a good medication, especially for kids.” 

“But it’s often too expensive for many people,” he said. As a result, he added, some of his patients had to turn to other medications instead, and sometimes those medications didn’t always work out. For example, one older patient didn’t tolerate the alternative well and developed yeast infections as a result. 

“I’ll put more patients back on the new generic option,” says Dr. Courville. 

The Asthma and Allergy Foundation of America (AAFA) also welcomed the news. “On behalf of the more than 28 million people in the United States with asthma, we welcome the news that a popular treatment option may be more affordable through a generic offering,” says Kenneth Mendez, president and CEO of the AAFA. “Approval is only the first step. The broken incentives that govern insurance formularies and PBM rebates haven’t changed. Congress still needs to act to ensure that cheaper medications actually reach the patients who need them.”

Once Flovent generic is available on the market, your pharmacist may switch you to a different generic. They can also review any differences in packaging or directions for use.

Bottom line

With the discontinuation of the name-brand Flovent, authorized generics were the only option for patients who wanted to continue using the same inhaled medication to manage their asthma. The FDA’s approval of a true generic of Flovent HFA (fluticasone propionate) inhalation aerosol marks a new chapter for patients who rely on fluticasone inhalers for asthma control.