FDA Approves First Generic of Proventil HFA, A Commonly Used Albuterol Inhaler

The United States Food and Drug Administration (US FDA) has approved the first generic of Proventil HFA metered-dose inhaler. This is an especially important approval for the COVID-19 pandemic response. Proventil HFA (albuterol sulfate) and its generic are used to provide quick relief from bronchospasms caused by COPD. The generic inhaler can be used by people 4 years old and older.¹

How does the generic Proventil HFA work?

Albuterol is a rescue medication for COPD. It treats bronchospasms that occur during a flare or exacerbation.² When the smooth muscles of the airways swell and tighten, it is called a bronchospasm. This leads to wheezing, chest discomfort, shortness of breath, and coughing.³

Albuterol belongs to a class of drugs called short-acting beta-agonists (SABAs). When inhaled, albuterol causes the smooth muscles of the airways to relax. This helps them open up, improving breathing and other COPD symptoms. As mentioned, albuterol is a rescue, or short-term, medication. It is not meant for the long-term maintenance treatment of COPD.²

The need for albuterol in the COVID-19 era

In addition to treating COPD, albuterol is sometimes prescribed to people experiencing shortness of breath for other reasons. This may include asthma, pneumonia, or other respiratory issues.²

A common symptom of COVID-19 is shortness of breath, often related to pneumonia. This can cause severe distress and discomfort. Doctors are working hard to figure out the best treatment options for COVID-19. However, in the meantime, we are relying mostly on treating the individual symptoms of the virus rather than curing it. In order to help reduce shortness of breath and the anxiety that comes along with it, some doctors are prescribing albuterol to people who normally would not be taking it otherwise.⁴

While this is helpful for the person in need, it does have wider impacts. With so many new people needing albuterol during the pandemic, the supply of commonly used albuterol inhalers has gone down. Although pharmaceutical companies have been trying to increase their supply, the US FDA has been taking additional steps to ensure we have as much albuterol as possible. This includes approving generic versions of albuterol inhalers, like Proventil HFA. This helps increase the albuterol supply. These are also less expensive than their branded counterparts.⁴

Determining when drugs are generics

Typically, when a drug’s patent expires, other pharmaceutical companies can begin to make generic versions of that drug. This is often an easier process for drugs that come in oral tablet forms or other simple doses. However, many albuterol products on the market come in metered-dose inhalers. These are considered complex combination products with unique dosing requirements and devices that can be hard to copy. This makes it more challenging to get generics on the market quickly and easily.⁵

To help make this process smoother, the US FDA has programs to help with generic drug development. One of these is called the pre-Abbreviated New Drug Application (ANDA) program. This program was essential in helping get the new generic version of Proventil HFA on the market.⁵

What are the side effects of generic Proventil HFA?

The most common side effects of the generic version of Proventil HFA are similar to its branded counterpart. These include:¹

• Upper respiratory tract infection
• Runny or itchy nose
• Fast heart rate
• Nervousness
• Tremor (shakiness)
• Nausea
• Vomiting

This is not an exhaustive list of all side effects. Talk with your doctor before starting any albuterol-containing product.¹