NPS Pharmaceuticals Inc announced the U.S. Food and Drug Administration had extended the review date for its hormone replacement therapy by three months to provide time for a full review of a “major amendment.”
The FDA also asked the company to submit a Risk Evaluation and Mitigation Strategy (REMS) for the drug, Natpara.
The regulator requires a REMS to ensure that the benefits of a drug outweigh its risks.
NPS’s shares fell 4.4 percent to $27.80 in extended trading on Thursday.
The FDA extension follows an 8-5 vote in favor of the drug’s approval by an FDA advisory panel in September.
The drug is designed to treat low levels of the parathyroid hormone (PTH), which causes hypoparathyroidism.
Source: Oct 23 (Reuters) – for complete story visit http://www.reuters.com/article/2014/10/23/nps-pharma-fda-idUSL3N0SI6R920141023