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Teva wins FDA nod for Qvar RediHaler device

August 7, 2017 By Sarah Faulkner

Teva PharmaceuticalTeva Pharmaceuticals (NYSE:TEVA) said today that the FDA approved its Qvar RediHaler breath-actuated inhaler for the maintenance treatment of asthma in patients ages 4 and older.

The device, which is not indicated for acute bronchospasm, is slated to become commercially available during the first quarter of 2018.

Unlike conventional metered-dose inhalers, the Qvar RediHaler does not necessitate hand-breath coordination during inhalation, according to Teva. The device also does not need to be shaken or primed before use.

“When working to manage asthma on a daily basis, proper administration of medication is of paramount importance,” Dr. Warner Carr, associate medical director of Southern California Research at Allergy and Asthma Associates of Southern California Medical Group, said in prepared remarks. “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.”

“It’s important that we uncover new opportunities to take longstanding, clinically effective medications, such as Qvar, and incorporate them into device technologies that may help address key ongoing issues for patients, including inhaler technique,” Dr. Tushar Shah, Teva’s head of late stage development, added. “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.”

The first-gen Qvar device was approved in 2014, but Teva said it plans to discontinue sales of the current Qvar metered-dose inhaler after the Qvar RediHaler launches in 2018.

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Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: Teva Pharmaceuticals

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Reader Interactions

Comments

  1. G. Old says

    August 7, 2017 at 2:52 pm

    I think that they should not discontinue sales of the current Qvar metered-dose inhaler after the Qvar RediHaler launches in 2018 – instead they should sell both, the new one in a little higher price. This would diversify their offering and justify the higher price.

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