Dalvance: First QIDP Antibiotic Breaks New Regulatory Ground; Label Doesn’t
Durata has post-marketing requirements to continue resistance-related studies, but its label includes stewardship language similar to other antibiotics.
You may also be interested in...
With a Special Protocol Agreement and an experienced sales team lined up, all the firm has to do now is get hospitals excited about an expensive antibiotic in a highly-genericized market.
Second QIDP antibiotic is first to market; Cubist will stress shorter term dosing over available therapies and thinks it can rely on efficient marketing strategy for commercial success.
Final rule includes a total of 21 pathogens, but agency notes a drug intended to treat a pathogen on the list is not guaranteed a QIDP designation for priority review and potential added marketing exclusivity.