Multiple Myeloma

FDA grants priority review for Velcade

Published in Medical Letter on the CDC and FDA, April 6th, 2003

Millennium Pharmaceuticals, Inc. (MLNM) has announced that the U.S. Food and Drug Administration (FDA) accepted for review and granted Priority Review designation of the company's New Drug Application (NDA) for Velcade for the treatment of relapsed and refractory multiple myeloma.

Priority Review is granted by the FDA to an NDA for a new treatment that addresses an unmet medical need. The FDA expedites the approval process for such an NDA by reducing the target review period for the application from 10 months to 6 months. Acceptance of the filing means that FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive...

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Source: Medical Letter on the CDC and FDA (2003-04-06)

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