FDA Approves Generic for Symbicort

Last updated: April 2022

On March 15, 2022, the Food and Drug Administration (FDA) approved the first generic for Symbicort®. Symbicort is a metered-dose inhaler for treating asthma and COPD (chronic obstructive pulmonary disease). Symbicort is one of the most prescribed treatments for asthma and COPD.

What are the active ingredients?

Like Symbicort, the generic is a dual-acting inhaler. It contains 2 active drugs. One is a steroid that reduces inflammation (budesonide). The second is a bronchodilator that relaxes airway muscles to aid breathing (formoterol).1-2

What is a generic?

Generic drugs are developed to be the same as brand-name drugs. Generics work in the same way as brand-name drugs. They have the same:

  • Active ingredients
  • Safety
  • Quality
  • Dosage
  • Strength
  • Intended use
  • Method of delivery
  • Risks and benefits

A generic may have minor differences from the brand-name drug. The differences are typically in the inactive ingredients. All mass-produced drugs have slight variations from batch to batch. The FDA limits how much batches can differ. When a drug gains approval, the FDA finds these variations statistically insignificant. The FDA’s approval of a generic means more people have access to the drug.2-4

Asthma

Asthma impacts over 25 million people in the United States. Over 5 million are children. Approving a generic increases access to treatment. When prescribed for asthma, this drug helps prevent symptoms like wheezing, coughing, and shortness of breath. It is approved for people 6 years and older who have asthma.

The most common side effects for those with asthma are:2

  • Upper respiratory infections
  • Headache
  • Swelling of the back of the throat and nasal passages (nasopharyngitis)
  • Influenza
  • Back pain
  • Thrush
  • Nasal congestion
  • Nausea and vomiting
  • Sinusitis
  • Mouth and nose (pharyngolaryngeal) pain

COPD

COPD is the fourth leading cause of death in the United States. More than 15 million people are diagnosed with COPD. A generic for Symbicort will help more people be able to manage their COPD. When prescribed for COPD, this generic improves breathing and reduces shortness of breath. Common side effects for those with COPD include:2,5

  • Upper respiratory tract infection
  • Bronchitis
  • Sinusitis
  • Swelling of the back of the throat and nasal passages (nasopharyngitis)
  • Thrush

Disclaimer: These are not all the possible side effects of budesonide and formoterol fumarate dihydrate inhalation aerosol for asthma or COPD. Talk to your doctor about what to expect when taking this drug. You also should call your doctor if you have any changes that concern you when taking this generic.

Things to know

Budesonide and formoterol fumarate dihydrate inhalation aerosol is prescribed for 2 doses each day. Doses should be about 12 hours apart, typically taken morning and evening. Drug delivery is through a metered-dose inhaler. The prescription comes in 2 different strengths per actuation:

  • 160/4.5 mcg
  • 80/4.5 mcg

Before beginning treatment, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs. For more information, read the full prescribing information of budesonide and formoterol fumarate dihydrate inhalation aerosol.2,6

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