FDA Guidance Smoothes Advair Generic Approval Process

Law360, Washington (September 11, 2013, 3:13 PM EDT) -- The U.S Food and Drug Administration on Monday issued a draft guidance on how drugmakers should test any planned generic version of GlaxoSmithKline PLC’s blockbuster asthma drug Advair, potentially smoothing the way for easier regulatory approval of generic versions once all relevant patents expire.

According to a Federal Register notice on Tuesday announcing the draft’s availability, the guidance provides specific recommendations for the design of studies of bioequivalence, or BE — a measure of whether a generic drug acts the same in the body as its...
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