NPS Pharmaceuticals Inc. announces FDA Extends Review Date For it’s HRT drug

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

 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s