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FDA approves NPS's Natpara with boxed warning

January 24, 2015 2:16 AM UTC

FDA approved Natpara from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. The recombinant human parathyroid hormone 1-84 (PTH) is the first parathyroid hormone approved for the indication.

NPS said it plans to launch Natpara in 2Q15. The drug, known in Europe as Natpar, is under EMA review. It has Orphan drug designation in both the U.S. and EU. ...