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REGULATORY NEWS

Proposed changes in labels for testosterone replacement therapy (TRT) products sent ripples across the space, after the first of a two-day meeting of FDA advisors concluded with a 20-1 vote that the drugs ought only to be used in classic hypogonadism – low testosterone due to testicular or disease of the hypothalamic/pituitary glands.

A mixed but positive FDA advisory panel vote combined with the looming Oct. 24 PDUFA date cast into question whether NPS Pharmaceuticals Inc.'s recombinant human parathyroid hormone for hypoparathyroidism, Natpara, will be approved without delay.
Ahead of Friday's FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting, briefing materials have been posted related to the biologic license application (BLA) for Natpara (rhPTH[1-84]) developed by NPS Pharmaceuticals Inc., of Bedminster, N.J.
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