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NPS Pharmaceuticals Inc announces FDA acceptance of Biologics License Application for Natpara for treatment of hypoparathyroidism

Tuesday, 7 Jan 2014 06:35pm EST 

NPS Pharmaceuticals Inc:Says that the U.S. Food and Drug Administration (FDA) has accepted and filed for review the company's Biologics License Application (BLA) for Natpara (recombinant human parathyroid hormone 1-84, (rhPTH 1-84)) for the treatment of hypoparathyroidism.Says under the Prescription Drug User Fee Act (PDUFA), the goal date for a decision by the FDA is Oct. 24.Says Natpara is a bioengineered replacement for endogenous parathyroid hormone (PTH) that NPS has developed for the treatment of hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, a principal regulator of the body`s mineral homeostasis.Says the FDA and European Medicines Agency have granted orphan drug status for Natpara for the treatment of hypoparathyroidism. 

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11 Jul 2014