Federal Food & Drug Administration

Federal Food & Drug Administration12 posts
9 Jul, 2015

Painkiller warnings strengthened

Makes Statement

FDA strengthens warning levels for painkillers that increase the risk of strokes and heart attacks, further warning individuals with a history of heart attacks, hypertension, or other heart disease to be cautious about using non-steroidal inflammatory drugs (NSAID). This is in response to recent data that show the increase in the risk of strokes and heart attacks following short-term NSAID use. FDA requires drug makers to update warnings on common products that contain NSAIDs such as Motrin, Advil, Aleve and other products used for the management of pain, fever, and inflammation. The one exception to the warning is aspirin.

11 May, 2015

FDA clears Neuroderm clinical trials

Makes Statement

The FDA clears Israeli pharmaceutical firm NeuroDerm’s U.S. clinical studies to proceed in the second half of this year.

Having lifted the clinical hold in the first half of 2015 means that our U.S. clinical development program of ND0612H and ND0612L is proceeding on track. Parkinson’s patients have been hoping for a less invasive, non-surgical alternative that can deliver levodopa continuously. We remain committed to the execution of our plan to bring these product candidates to the market as soon as possible, and to make a significant impact on the lives of Parkinson’s patients.

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