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Natpara action date October 2014 for hypoparathyroidism indication
January 8, 2014
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
The FDA has accepted the BLA from NPS Pharmaceuticals for Natpara (recombinant human parathyroid hormone 1-84, (rhPTH[1-84])) for the treatment of hypoparathyroidism. Under the Prescription Drug User Fee Act (PDUFA), the goal date for a decision by the FDA is October 24, 2014. 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...
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