Bevespi Aerosphere Approved
April 25, 2016 – The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Bevespi Aerosphere™ (glycopyrrolate/formoterol fumarate) inhalation aerosol. Bevespi Aerosphere is indicated for use as maintenance treatment for chronic obstructive pulmonary disease (COPD) and provides a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA). The recommended dose is two oral inhalations in the morning and two in the evening, each dose containing 9mcg of glycopyrrolate and 4.8mcg of formoterol fumarate. Labeling for Bevespi Aerosphere carries a boxed warning indicating that it increases the chance of death among asthma patients, so it should not be used to treat asthma. It uses a proprietary new formulation technique, Co-Suspension™ Technology, that is intended to keep the drug mix consistent both within the inhaler device and in the lungs.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.