FDA issues guidelines for prospective makers of generic asthma, COPD drug

GSK's Advair Diskus loses patent protection in 2016

NEW YORK — A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

The FDA guidelines, a set of non-binding recommendations released Monday, outline studies that manufacturers can conduct to determine equivalence between GSK's Advair Diskus (fluticasone propionate; salmeterol xinafoate) and generic versions.

The main drug used in Advair Diskus loses patent protection in 2016, but it has been widely considered safer from generic competition than other drugs because it combines the drug and a device in the form of a special inhaler. According to the FDA guidelines, a generic drug company could theoretically win approval for a generic equivalent to the Advair Diskus if it develops an inhalation device that delivers the drug in a manner equivalent to the branded version.

Advair Diskus had sales of $4.9 billion, according to IMS Health.


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