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Article: FDA Accepts CUBICIN(R) sNDA and Grants Priority Review.
- Article from:
- Business Wire
- Article date:
- November 21, 2005
CopyrightCOPYRIGHT 2005 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that it has received notice from the U.S. Food & Drug Administration (FDA) that the Supplemental New Drug Application (sNDA) for Cubist's antibiotic CUBICIN(R) (daptomycin for injection) has been accepted and has been granted priority review status. The FDA grants priority review to products it believes represent a therapeutic advance over existing medicines. By granting priority review status to CUBICIN, the FDA has established a target date to act on the sNDA filing by March 24, 2006.
Cubist submitted the CUBICIN sNDA on September 26, 2005, requesting approval for a new indication ...