Stiolto Respimat Approved
May 21, 2015 - The U.S. Food and Drug Administration (FDA) approved Stiolto™ Respimat® Inhalation Spray manufactured by Boehringer Ingelheim. Stiolto Respimat is a combination of tiotropium, a long-acting muscarinic antagonist (LAMA) and olodaterol, a long-acting beta-2 agonist (LABA). For long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), Stiolto Respimat is used once a day. It is not indicated for acute COPD flare-ups or asthma.
The Respimat inhaler device delivers mist more slowly than some other inhalers, making inhalation easier for some patients. As with other LABAs, the labeling for Stiolto Respimat carries a boxed warning that the risk of an asthma-related death is increased by patients using a LABA. Stiolto Respimat will share the market with the LAMA/LABA combination product Anoro® Ellipta® (umeclidinium/vilanterol) manufactured by GlaxoSmithKline as well as the combination glycopyrronium and indacaterol, QVA149, manufactured by Novartis which could receive approval for COPD in the fourth quarter of 2015.
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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.