FDA OKs QVAR RediHaler for Asthma in Children Aged 4+

Megan Brooks

Disclosures

August 11, 2017

The US Food and Drug Administration (FDA) has approved beclomethasone dipropionate HFA inhalation aerosol (QVAR RediHaler, Teva Pharmaceuticals), a breath-actuated inhaler for the maintenance treatment of asthma in children aged 4 years and older.

QVAR RediHaler. Photo courtesy of Teva

The QVAR RediHaler contains the same active drug found in QVAR inhalation aerosol, which the FDA approved in 2014. But unlike QVAR, QVAR RediHaler delivers the medication via a breath-actuated metered-dose inhaler (MDI), eliminating the need for hand-breath coordination during inhalation.

"When working to manage asthma on a daily basis, proper administration of medication is of paramount importance," Warner W. Carr, MD, associate medical director of Southern California Research at Allergy and Asthma Associates of Southern California Medical Group in Mission Viejo, said in a company news release.

"However, research has indicated that approximately 76% of patients still struggle to use their MDI inhalers correctly, thus placing them at increased risk for asthma exacerbations. From a clinical perspective, QVAR RediHaler is a much-needed treatment option for these patients who may be experiencing continued difficulty with hand-breath coordination," said Dr Carr.

"The FDA approval of QVAR RediHaler brings to market inhaler technology aimed at enabling patients to more accurately administer the medication and ensuring they are receiving a proper dose with each inhalation," added Tushar Shah, MD, from Teva Pharmaceuticals.

The company expects QVAR RediHaler to be available in 40-µg and 80-µg strengths during the first quarter of 2018. Teva plans to take QVAR off the market with launch of QVAR RediHaler.

Full prescribing information and a patient guide are available online.

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