August 20, 2009 / 9:50 PM / 10 years ago

UPDATE 1-Medicines Co withdraws European application for drug

Aug 20 (Reuters) - Medicines Co (MDCO.O) said it withdrew the European marketing application for its experimental antibiotic, oritavancin, after the European Medicines Agency indicated that another trial would be required before approval could be considered.

The U.S. Food and Drug Administration also raised similar concerns about the drug, the company said in a statement.

Last December, the FDA had declined approval for oritavancin and raised questions about the safety of the drug.

The European marketing application was filed in June 2008 by Targanta Therapeutics Corp, which Medicines acquired in February 2009.

Medicines said it was in discussions with the FDA regarding a clinical trial for oritavancin and also intends to confer with European regulators regarding the design of the trial.

The company expects to start the trial in the fourth quarter.

Shares of the company closed at $7.80 Thursday on Nasdaq. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Vinu Pilakkott)

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