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FDA accepts Delcath's application for drug-device chemotherapy combo

Wed, 10/17/2012 - 8:45am
Mass Device

The FDA accepts for review Delcath's 2nd new drug application, bringing the device maker one step closer to launching its ChemoSat drug-device combination on the U.S. market.

Delcath chemo isolation delivery system

The FDA agreed to review Delcath Systems' (NSDQ:DCTH) new drug application, bringing the device maker 1 step closer to launching its organ-isolating chemotherapy system on the U.S. market.

The federal watchdog agency designated the application, Delcath's 2nd attempt at approval, for standard review. Delcath expects to be notified of its panel date by the end of the month, according to a press release.

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