Posted from: Tuesday, January 16, 2018 - 01:22 PM - Present

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.

Actual drug patent expiration dates and 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.

Last Updated Friday, May 25, 2018 - 08:34 AM.