According to Lannett, the FDA has set a GDUFA goal date of January 31, 2022 for completion of its review of the ANDA for Respirent’s generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of asthma and COPD.
The submission of the ANDA was announced in April 2021 by Lannett, which acquired US rights to the generic version of Advair Diskus in October 2019. In August 2020, Lannett also acquired US rights to Respirent’s generic Flovent Diskus fluticasone propionate DPI.
Lannett CEO Tim Crew said, “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. 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 US launch of the product in calendar 2022.”
Read the Lannett press release.
