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Lannett Announces FDA Acceptance, As A Priority Original ANDA, Of The Generic Advair Diskus Filing


Benzinga | Jun 1, 2021 06:54AM EDT

Lannett Announces FDA Acceptance, As A Priority Original ANDA, Of The Generic Advair Diskus Filing

Lannett Company, Inc. (NYSE:LCI) today announced the U.S. Food and Drug Administration (FDA) has accepted the Abbreviated New Drug Application (ANDA) for Fluticasone Propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg), which was submitted by Lannett on behalf of its strategic alliance partner, Respirent Pharmaceuticals Co. Ltd. The FDA assigned a Generic Drug User Fee Act of 2017 (GDUFA II) goal date for this priority original ANDA of January 31, 2022.






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