FDA rejects Novartis’ Advair generic, leaving GSK without rival

GlaxoSmithKline (NYSE:GSK) was granted a temporary win today after Novartis‘ (NYSE:NVS) Sandoz unit reported that the FDA rejected its application for a generic version of the company’s blockbuster lung treatment, Advair.

The regulatory agency reportedly told Novartis that it needs to submit additional clinical data before the FDA can make its final decision.

GSK said in its earnings report yesterday that if there is no generic competition for Advair this year, its earnings could increase 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.

Analysts expect that GSK’s Advair product will bring in more than $3B in sales this year, according to Bloomberg.

GSK shares jumped on the recently regulatory news, trading at $37.58 in pre-market activity today, up 4.4%. Meanwhile, NVS shares fell slightly, trading at $84.22 apiece before the market opened.

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