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Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

Breyna (budesonide/formoterol fumarate dihydrate – Viatris) inhalation aerosol, 80mcg/4.5mcg and 160mcg/4.5mcg, the first A-rated generic to Symbicort® (AstraZeneca) has been released in the United States. It was approved by the U.S. Food and Drug Administration (FDA) in March 2022. The combination of an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA), it treats asthma, but not acute bronchospasms, for patients as young as six years old who have not had adequate relief with other asthma-controlling medications. The higher strength also is approved as maintenance therapy for chronic obstructive pulmonary disease (COPD). Recommended dosing is two inhalations every day – at the lower dose to treat asthma for children under the age of 12 years, at the higher dose for COPD, and at either dose for patients aged 12 years and older who have asthma. Breyna is dispensed in 120-dose inhalers. The cost is not yet available. According to AstraZeneca’s 2022 annual report, U.S. sales of Symbicort for the calendar year amounted to $973 million.

At a Glance

  • Brand Drug/Manufacturer: Symbicort/AstraZeneca
  • Generic Name/Manufacturer: Breyna/Viatris
  • Indication: to treat asthma for patients six years of age and older, and to relieve airflow obstruction and reduce exacerbations for patients who have COPD, including chronic bronchitis and/or emphysema.
  • Dosage Forms Available: multi-dose inhalers containing 120 inhalations of either 80mcg or 160mcg of budesonide and 4.5mcg of formoterol
  • Launch Date: immediately
  • Estimated Annual Cost: Pricing information is not yet available.
  • Annual U.S. Sales: $973 million for 2022
  • According to the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS), about 6.2% of American children under the age of 18 years and 8.7% of adults over 18 years have asthma.
  • COPD has been diagnosed at some time for roughly 4.6% of the U.S. population – mostly older adults.
  • Budesonide, an ICS, inhibits inflammation; the LABA, formoterol, dilates the bronchial tubes in the lungs. Together, they prevent attacks of asthma and COPD.
  • Breyna is a complex generic – it includes not only the drugs but also the inhalation device manufactured by Kindeva Drug Delivery, which partners with Viatris.
  • Prasco launched an authorized generic of Symbicort in January 2020.

Teva is developing an A-rated generic for Symbicort. The launch date is unknown; however, it is expected within the next six months pending FDA approval.