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Generic Drugmakers Get Boost as FDA Move Helps Complex Copycats

Oct. 9, 2018, 3:23 PM

The U.S. Food and Drug Administration will make it easier for pharmaceutical companies to bring more complex -- and more profitable -- generic drugs to market, throwing the struggling industry a crucial lifeline.

Unlike relatively simple pills, drugs that combine a medicine with a delivery device can be harder to copy and therefore often don’t have generic competition. For manufacturers that do the extra work required to bring such products to market, they can be more profitable. But regulatory hurdles have made getting them approved more difficult, FDA Commissioner Scott Gottlieb said Tuesday, at a time when generic drug manufacturers ...