12:00 AM
Oct 29, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Contrave regulatory update

Orexigen said FDA denied the company's request to immediately review and issue a decision on an NDA for Contrave instead of waiting for data from the agency-required cardiovascular study of the obesity product. However, Orexigen said that FDA is open to the possibility of a "faster path" to resubmission than the biotech had previously expected. Orexigen could resubmit the application before interim results, with the data submitted later during the review period. Orexigen did not provide a timeline for...

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