FDA accepts Lannett's application for generic Advair Diskus; GDUFA II goal date is January 31, 2022
Jun. 01, 2021 9:05 AM ETLannett Company, Inc. (LCI)By: Mamta Mayani, SA News Editor
Lannett Company (NYSE:LCI) perks up 3% premarket in reaction to the announcement that the 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 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 January 31, 2022.
The company is positioned for a potential U.S. launch in calendar 2022.
The product is the generic equivalent of Advair Diskus of GlaxoSmithKline.
According to IQVIA, total U.S. sales of the product were ~$3B for the 12 months ending April 2021.
Now read: Lannett Company, Inc. (LCI) CEO Tim Crew on Q3 2021 Results - Earnings Call Transcript
