For the second time in a row the Silenor drug for Insomnia has been declined. Apparently the drug did not meet the approval standards for efficacy though no clinical issues were being placed in question. The FDA has requested the company to submit an amended risk evaluation and mitigation strategy (REMS), including a medication guide to be distributed with the product.
Apparently this has been affecting the share value of the company which has dropped by more than 60%. The FDA declined to approve the drug back in February after citing concerns relating to heart health were the drug was concerned.
(Source) DB Techno
Also see other interesting tags at SleepZine: approval standards, efficacy, fda, heart health, insomnia drug, medication, medication guide, mitigation strategy, risk evaluation, second time, share value
