Tuesday, April 3, 2012

Reuters: Regulatory News: UPDATE 1-FDA extends action date for Navidea's tracer agent

Reuters: Regulatory News
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UPDATE 1-FDA extends action date for Navidea's tracer agent
Apr 3rd 2012, 13:52

Tue Apr 3, 2012 9:52am EDT

* Extends review date by 90 days.

April 3 (Reuters) - Navidea Biopharmaceuticals Inc said U.S. health regulators have extended the action date for its radioactive agent by 90 days to Sept. 10.

The U.S. Food and Drug Administration had set an initial action date of June 10 for Lymphoseek, a radioactive agent to locate lymph nodes in cancer patients.

On March 30 the company said it submitted certain data sought by the regulators for approval of its product.

Shares of Navidea were down 8 percent at $3.04 on the NYSE Amex.

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