King Pharma Imaging Agent Could Face FDA Delay
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BRISTOL, Tenn. (AP) — King Pharmaceuticals Inc. said Wednesday it received a Food and Drug Administration request for more information on the experimental stress imaging agent CorVue.
The company is seeking FDA approval to sell the product as an injectable imaging agent for use in assessing patients how have or are at risk for coronary artery disease. The FDA sent the company a "complete response letter" which normally entails a request for information. King did not disclose the nature of the request. Similar letters can ask for anything ranging from additional data that is already available to a need for a company to conduct additional studies. The company said it is currently evaluating the request and expects to respond to respond as quickly as possible. Shares of King Pharmaceuticals fell 5 cents to $10.89 in morning trading.- Loading Comments...
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