A hand holding up a sign with a picture of a red inhaler.

First Generic of ProAir HFA Approved

The United States Food and Drug Administration (US FDA) has approved the first generic of ProAir HFA.1 ProAir HFA (albuterol sulfate) Inhalation Aerosol is a rescue medication used to treat asthma attacks. Both ProAir HFA and the new generic can be taken by people 4 years old and older.

How does the generic ProAir HFA work?

Albuterol is a short-acting beta agonist (SABA) that acts on the airways. It relaxes the smooth muscles of the airways to help improve breathing within minutes. Rescue drugs like albuterol are not meant for the long-term or maintenance treatment of asthma. Instead, they are used to help open the airways during an asthma attack or shortly before an asthma attack is expected to begin (such as before exercise or exposure to a trigger).

Why is this approval important?

ProAir HFA and other brand name albuterol products often come in a metered dose inhaler. These metered dose inhalers are complex, making it challenging to create generic versions. This is especially true when compared to other kinds of drugs like tablets.

After a brand name drug’s patent has expired, pharmaceutical companies can begin to make generic versions of it. However, when a drug or the way it is administered is more complex, like albuterol in a metered dose inhaler, it can be challenging to quickly create a suitable generic.

Without generics on the market, drug prices can be expensive. People needing these drugs may have few other alternatives and may spend lots of money on the brand names. By creating a generic version of such a commonly used drug, like ProAir HFA, more people may have access to affordable treatment options. The new generic may also be covered by more insurance companies. Since the new generic can be used by ages 4 and older, this approval may have wide-reaching impacts throughout the asthma community.

Determining when drugs are generics

The FDA has several programs designed to help guide the development of generic products, including generics of complex brand name products. One program is called the pre-Abbreviated New Drug Application (ANDA) program. Efforts like this aim to get more generic products on the market and reduce drug costs for those in need.

In order to be evaluated and approved as a generic, pharmaceutical companies need to submit a lot of information and data showing that their product is as safe and effective as the brand name drug it is modeled after.

The ProAir HFA generic is manufactured by Perrigo Pharmaceutical Company. By the end of 2020, the generic should be available on the market. The generic has been approved as an AB-rated generic. This means, it contains the same active ingredient as a brand name drug, and meets the standards set forth by the FDA when it comes to equivalence, safety, and effectiveness.

What are side effects of the generic ProAir HFA?

The most common side effects of the generic version of ProAir HFA are similar to the brand name. They include, but are not limited to:1

  • Headache
  • Dizziness
  • Sore throat
  • Runny nose
  • Heart palpitations
  • Tremor
  • Chest pain
  • Nervousness

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