New Delivery System Approved for QVAR
August 3, 2017 – The U.S. FDA has approved QVAR® RediHaler™ (beclomethasone dipropionate HFA), manufactured by Teva Pharmaceuticals. QVAR RediHaler is a breath-actuated inhalation device that contains a corticosteroid indicated for long-term preventive maintenance of asthma. The device and medication can be used by patients as young as four years old. Unlike other inhalation devices, there is no need to squeeze the RediHaler, and it does not need to be shaken, primed, or used with a spacer. The patient simply inhales from the RediHaler to activate delivery of their medication. Depending on the patient’s age and the severity of their asthma, recommended dosing can range from 40mcg to 320mcg twice a day. QVAR RediHalers will be available in two forms, one that delivers 40mcg of medication per inhalation, and one that delivers 80mcg per inhalation. Release is scheduled for the first quarter of 2018.
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
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.