Jazz Pharmaceuticals Inc (JAZZ.O) said the U.S. health regulator did not approve its experimental drug to treat the pain disorder fibromyalgia and suggested the need for additional clinical studies.
The U.S. Food and Drug Administration's (FDA) complete response letter said the drug, JZP-6, could not be approved in its present form and "discusses a number of topics, including the need for additional clinical studies," Jazz Pharma said in a statement.
via reuters.com
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