After months of anticipation, the FDA has issued a so-called final guidance for approving new treatments that contain more than one drug. And the agency decision is likely to stir controversy because untold amounts of money may be at stake. Here’s why. Such drugs are known as fixed-dose combinations and, until now, five years of valuable marketing exclusivity are available if all of the drugs in the combination are new chemical entities. Simply put, these would be drugs that were not previously approved for any use. A fixed-dose combination containing an older drug would be eligible for three years of exclusivity instead.
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