Don’t expect a generic Advair any time soon. The FDA has declined to approve Mylan’s version of the asthma drug, currently produced by GlaxoSmithKline, Medscape reports.
Mylan said it received a so-called complete response letter (CRL) from the FDA, which had been expected to decide by Tuesday whether to approve the first generic copy of Advair, a two-part inhaled drug used to treat asthma and chronic lung disease.
The FDA leaves it to companies to disclose the contents of any CRL it issues. They can contain demands for additional clinical trials that can take years, or involve minor delays as the agency reviews additional data or complete inspections of manufacturing plants.
The drugmaker issued a statement saying it was reviewing the FDA’s response and would provide an update on its application “as soon as practicable.”
What is clear is that GSK has gained additional time to sell Advair without facing competition from a cheap generic, a welcome reprieve for its incoming Chief Executive Emma Walmsley who takes over later this week.
Get the whole story at www.medscape.com