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Sicor, Inc.

FDA gives ANDA approval for norepinephrine bitartrate injection

Published in Drug Week, March 28th, 2003

Sicor, Inc., (SCRI) announced that its wholly owned subsidiary, Gensia Sicor Pharmaceuticals, Inc., has received approval of an abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for norepinephrine bitartrate injection.

Norepinephrine bitartrate is used to restore blood pressure and control acute hypotensive states and as an adjunct in the treatment of cardiac arrest and profound hypotension.

The product is packaged in an ampule.

Gensia Sicor's version of norepinephrine injection will be available in a user-friendly 5 mL flip-top vial.

This article was prepared by Drug Week...

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