CV Therapeutics has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of ranolazine in the EU for the treatment of chronic angina.
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Following this positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), CV Therapeutics expects the European Commission to issue full marketing authorization for ranolazine by the end of June, 2008. The brand name for ranolazine in the product labeling is Latixa.
Louis Lange, chairman and CEO of CV Therapeutics, said: “This positive opinion from the CHMP brings ranolazine significantly closer to physicians and patients in Europe for the treatment of chronic angina. The strong first-in-class product labeling should position ranolazine very favorably with potential partners and allow for broad patient acceptance and premium pricing in the European market.”
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