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FDA approves first generic of Proventil HFA

Jennifer Larson writer headshot By | April 14, 2020
Medically reviewed by Karen Berger, Pharm.D.

The U.S. Food and Drug Administration (FDA) granted approval to Cipla Limited to manufacture the first generic version of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90 mcg/inhalation.

Merck, the manufacturer of ProAir, released an authorized generic of ProAir in April 2019, supplied and distributed through one of Endo International’s operating companies, Par Pharmaceuticals. This new generic version is the first copy of the original formulation, not produced by Merck. Meaning, it’s adding new competition to the market, which should help to decrease price. 

What is Proventil generic?

This particular type of inhaler, sometimes referred to as a rescue inhaler, is intended to be used to prevent or treat bronchospasm in people aged 4 years and older who have reversible obstructive airway disease. It can also be used for the prevention of exercise-induced bronchospasm. Approximately 25 million people, including almost 7 million children, in the United States have asthma, according to the Centers for Disease Control and Prevention (CDC).

ProAir HFA (albuterol inhaler) and Proventil HFA (albuterol inhaler) are among the most commonly used albuterol sulfate versions of short-acting bronchodilators on the market. Others include Ventolin HFA (albuterol inhaler) and AccuNeb (albuterol nebulizer solution). 

What are the side effects of Proventil HFA generic?

The most common side effects for this type of medication include rhinitis, nausea, vomiting, rapid heart rate, tremor, nervousness, and upper respiratory tract infection, according to the FDA.

The benefits of Proventil HFA generic

This approval comes just a few weeks after the FDA approved another generic albuterol inhaler. The FDA gave approval to Perrigo Pharmaceutical Company to start manufacturing the first generic of ProAir HFA (albuterol sulfate) inhalation aerosol in late February.

Generally speaking, the release of another generic form of albuterol is good news for people who need this kind of medication, according to allergist J. Allen Meadows, MD, president of the American College of Allergy, Asthma and Immunology (ACAAI).

“It increases the supply and decreases the cost some, modestly,” Dr. Meadows says.

A time of increased demand

According to FDA Commissioner Stephen M. Hahn, MD, there’s already a growing demand for this type of product.

 “The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” Dr. Hahn said in a statement announcing the approval on April 8. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”

Several weeks ago, the ACAAI released a statement acknowledging shortages of albuterol inhalers in certain parts of the country, due in part to an increased use of inhalers for hospitalized patients with COVID-19 infections. Some hospitals were curtailing the use of nebulizers out of concerns that they could spread the virus through the air.

But the ACAAI reminded people not to panic and not to worry about stocking up, as one canister of albuterol should last for months. According to Dr. Meadows, one rescue inhaler should last six to 18 months. If you’re using your rescue inhaler up sooner, you may not be controlling your asthma well enough. In that case, you may need to speak with your healthcare provider about adjusting or changing the prevention medication that you’re taking.

However, some people may still worry about shortages of albuterol rescue inhalers, so the news of another albuterol product hitting the market may be reassuring to them, says Dr. Meadows.

“We should have plenty—don’t worry,” he says.

When will Proventil generic be available?

At present, it’s unclear exactly when the new generic will hit the U.S. market. A statement released by Cipra on April 9 said, “We are planning shipments in a staggered manner. We are also ensuring that we do our bit by donating the product in this time of need.”