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June 1, 2021
“The FDA’s Acceptance of the ANDA submission of generic ADVAIR DISKUS® brings us one step closer to providing asthma patients an affordable option for this critical medication,” said Tim Crew, chief executive officer of Lannett. “We anticipate more than one FDA review cycle of this opportunity given the inherent complexity associated with a drug/device combination inhalation product. However, our partners at Respirent have assembled a comprehensive application and have expertise in developing and manufacturing dry powder inhalation products, so we believe we are positioned for a potential U.S. launch of the product in calendar 2022.”