FDA Reverses Course On Exclusivity For New Drug Combos

Law360, New York (February 21, 2014, 12:59 PM EST) -- In a major break with two decades of policy, the U.S. Food and Drug Administration on Friday said new prescription drugs that contain both original and previously approved active ingredients will be awarded five years of marketing exclusivity, up from three years.

The FDA's draft proposal, developed at the prodding of several drugmakers, emerges in response to the fast-growing field of multi-ingredient "cocktails" that target serious diseases, such as HIV, AIDS and cancer. For years, such products have qualified for much shorter exclusivity if they contain...
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