Lannett Co. Inc. (NASDAQ: LCI) stock declined by 12.96% at the last close whereas the LCI stock price surged by 3.02% in the pre-market trading session. Lannett Company, founded in 1942, is a generic pharmaceutical company that develops, produces, packages, promotes, and distributes medicines for a variety of medical reasons.
What is happening?
The FDA has approved the Abbreviated New Drug Application (ANDA) for Fluticasone Propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg, and 500/50 mcg) filed by Lannett on account of its strategic alliance partner, Respirent Pharmaceuticals Co. Ltd. For this priority original ANDA, the FDA set a target date of January 31, 2022, under the Generic Drug User Fee Act of 2017 (GDUFA II).
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The medication is a generic version of GlaxoSmithKline’s ADVAIR DISKUS®. However, according to IQVIA, total U.S. sales of the product were over $3 billion in the 12 months ending April 2021, while real generic market values are projected to be less
Also,
Lannett has signed into an exclusive U.S. distribution deal for Respirent’s medically comparable generic of Advair Diskus, as reported earlier. Lannett will begin distribution of the product in the United States after FDA clearance and will get a part of the net earnings after distribution begins. LCI recently agreed to extend the agreement’s length to 12 years following the start of distribution.
Tim Crew, CEO of Lannett commented:
With the FDA’s approval of the ANDA for generic ADVAIR DISKUS, LCI is one step closer to giving asthma patients a more affordable choice for this life-saving treatment. Due to the inherent complication of a drug/device combination inhalation product, LCI expects more than one FDA review cycle for this possibility. However, because their Respirent partners have put together a full application and have experience designing and manufacturing dry powder inhalation products, they feel they are in a good position to launch the product in the United States in calendar 2022.