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Pargluva Launch Likely Delayed
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The Food and Drug Administration has given only conditional approval to a diabetes drug from Bristol-Myers Squibb (BMY Quote) and Merck (MRK Quote), saying it wants more clinical test data before it signs off on the compound.
The FDA's decision, announced by both companies Tuesday, should push back the launch of the drug Pargluva by at least a year, analysts say.
The agency's response isn't surprising because an FDA advisory committee in early September raised questions about potential heart risks, even though it voted 8-1 to support the drug as a stand-alone treatment. ...
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