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Teva gets FDA clearance for QVAR RediHaler

SILVER SPRING, Md. — The Food and Drug Administration has approved Teva’s QVAR RediHaler (beclomethasone dipropionate HFA), the company announced Monday. The QVAR RediHaler is a breath-actuated inhaler for the maintenance of asthma as a prophylactic treatment in patients ages 4 years and older.

QVAR RediHaler is different from most metered-dose inhalers because it delivers medication through a breath-actuated metered-dose inhaler, which Teva said eliminates the need for hand-breath coordination during inhalation. The RediHaler contains the same active ingredient as QVAR Inhalation Aerosol. It also is designed to be used without shaking or priming, and should not be used with a spacer or volume holding chamber, Teva said.

Картинки по запросу Beclometasone dipropionate

“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,” Teva head of late stage development Dr. Tushar Shah said. “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.”

Teva said it expects the QVAR RediHaler to be available in 40- and 80-mcg dosage strengths in the first quarter of 2018. It also plans to discontinue its QVAR metered-dose inhaler at the same time.

August 7, 2017


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