03.01.2014 14:45:05
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NPS Pharma Gets Orphan Drug Designation For Natpara In Europe - Quick Facts
(RTTNews) - NPS Pharmaceuticals Inc. (NPSP) announced that the European Commission has granted orphan drug designation to Natpara (recombinant human parathyroid hormone (rhPTH[1-84]) for the treatment of hypoparathyroidism.
Natpara is a bioengineered replacement for endogenous parathyroid hormone or PTH that NPS has developed for the treatment of hypoparathyroidism, a rare endocrine disorder in which the body produces insufficient levels of parathyroid hormone, a principal regulatory of the body's mineral homeostasis.
The company said it was also granted orphan drug status by the U.S. Food and Drug Administration or FDA in 2007. The company submitted its U.S. Biologic License Application to FDA in October 2013.
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