Lonhala Magnair Approved for COPD
December 5, 2017 – The U.S. FDA has approved Lonhala™ Magnair™ (glycopyrrolate) inhalation solution, manufactured by Sunovion Pharmaceuticals, to provide continuing maintenance treatment of chronic obstructive pulmonary disease (COPD). A long-acting muscarinic antagonist (LAMA), Lonhala is the first drug of its type to be approved in a nebulized form to treat COPD.
Recommended dosing for Lonhala is one vial twice daily, using the Magnair nebulizer. Each 1mL vial contains 25mcg of Lonhala. The vials cannot be used with any other nebulizer. Patients should be trained by a healthcare professional in the proper administration of Lonhala via the Magnair device. Treatments are to be given at the same time each day—once in the morning, and once in the evening. Lonhala is not intended to be used during acute deterioration of COPD or life-threatening episodes. It is not a rescue therapy.
Sunovion plans to launch Lonhala™ Magnair™ in early 2018 in kits, which will contain the Magnair system and 60 vials of Lonhala. The system uses a handset similar to a multi-dose inhaler; replacement handsets will be included with prescription refills of the drug. Pricing details have not been announced.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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
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