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

 

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If You are Feeling Tired All The Time, It Could Mean You Need Hormone Therapy

Aging is an interesting thing. Your body changes so much over your lifespan. Your younger years are usually your healthiest, when you feel the most energenic, strong and carefree. As you age, you lose some these feeling. In some, the loss of energy can occur earlier than in others. What causes this? Well for 30 year old men and women, feeling tired all the time can be a indicator of hormone imbalance or difficiency. You may have seen the TV commercials “Is it low-T”? Well if you’re a 30+ year old, and you’re feeling less energy than you used to, or just tired more than usual, this commercial was directed toward you. You could have low testosterone, which is what “Low-T” means. If you’re feeling less energy, more tired than usual and it’s over a period of time, you should see a doctor. There’s a great doctor’s office that provides hormone therapy in Miami, they have an awesome spa there, too. They can test you for hormonal imbalance and if it’s determine that you can benefit from hormone replacement therapy, they can discuss your options and help you decide if it’s a good fit for you. Hormone replacement therapy isn’t going to be the answer for everyone, but for those who are suffering from hormone imbalance, HRT is a life-changer. Feeling young again is worth it, too.