Combo-drug-makers petition FDA on exclusivity period

01/31/2013 | Pharmalot.com

Ferring Pharmaceuticals and Gilead Sciences have petitioned the FDA to change how market exclusivity is granted for combination drugs. The agency grants five years' exclusivity if all active compounds in a combination drug are new and three years' exclusivity otherwise. The drugmakers say combination drugs are the same as new drugs and should be treated accordingly.

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