Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug.
Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects to wait until it receives the full notice on June 27 to determine how the rejection will impact its 2018 financial outlook.
For now, GSK can breath a collective sigh of relief. The company’s product brings in $3 billion in annual sales for the company and a number of companies are looking to take a bite out of that market. But so far, all of GSK’s competitors have received setbacks from the FDA. For example, the U.S. regulatory agency denied Novartis’ application for an Advair generic in February this year.
In its 2017 earnings report, GSK said that if there is no generic competition for Advair this year, its earnings could jump by as much as 7%.
The pharma company’s Advair drug-device combination is designed for asthma patients ages 4 and older. The fluticasone propionate/salmeterol device also treats airflow obstruction and lessens exacerbations in patients with chronic obstructive pulmonary disorder.
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