Posted by Michael Wonder on 01 Jun 2021
Lannett announces FDA acceptance, as a priority original ANDA, of the generic Advair Diskus filing
1 June 2021 - Lannett today announced the U.S. FDA has accepted the abbreviated new drug application 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.
The FDA assigned a Generic Drug User Fee Act of 2017 (GDUFA II) goal date for this priority original ANDA of 31 January 2022.
