Will FDA Widen Use For The Vasecpa Fish Oil Pill, After All?

In a surprising development that has revived intense speculation over the fate of Amarin, the FDA has delayed any decision about whether to widen an indication for the Vascepa prescription fish oil pill.  The move was expected in December 2013 and the delay has now triggered intrigue over what appears to be a complex minuet between the agency and the ‘little drugmaker that could.’

FDA Takes Action on Ambien; Concedes Women at Greater Risk

The FDA announced in December 2013 that it is recommending the bedtime dose of Zolpidem (brand name Ambien) be lowered due to the risk of next-morning impairment.  In a press release issued in December 2013, the FDA says it recommending the change “because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.”  The FDA is requiring manufacturers of Ambien, Ambien CR, Edluar and Zolpimist to lower the recommended dose “because use of lower doses of Zolpidem will result in lower blood levels in the morning.”

US Medical Device Regulator to Improve PMA, IDE Processes

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans revisions to its Investigational Device Exemption process to improve clinical trial management for manufacturers and sponsors, and may also consider down-classifying some devices from Class III Premarket Approval registration requirements.