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Article: Mimpara -- Cinacalcet HCl -- Receives Positive Regulatory Opinion for Approval in Europe.
- Article from:
- Business Wire
- Article date:
- July 30, 2004
CopyrightCOPYRIGHT 2004 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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THOUSAND OAKS, Calif. -- Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to approve marketing authorization for Mimpara(R) (cinacalcet HCl) in the European Union (EU) for the treatment of secondary hyperparathyroidism (HPT) in chronic kidney disease (CKD) patients on dialysis and the treatment of elevated calcium levels (hypercalcemia) in patients with parathyroid carcinoma. In the U.S., the drug is marketed as Sensipar(TM) and was approved by the Food and Drug Administration (FDA) following a priority review in March 2004. Mimpara is ...