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: Drug and Device LawOff-Label Promotion Criminal Trial Begins
By James M. Beck and Mark Herrmann
The main event started in San Francisco on Tuesday. For coverage of the opening statements in the criminal trial against the former CEO, Scott Harkonen, see the AmLaw Daily here and The Recorder here (subscription required).
Full post as published by Drug and Device Law on August 20, 2009 (boomark / email).
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The FDA is seeking to add black box warnings of the risk of tendon rupture associated with Cipro and Levaquin.
The ruptures can involve Achilles tendon, shoulder, hand, bicep or thumb tendons, and is especially increased in patients older than 60, or people who have received kidney, heart or lung transplants, as well as people on steroid therapy...

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