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CRL on Probuphine Raises Questions on Adcom Relevance

By Marie Powers
Staff Writer

Thursday, May 2, 2013
Titan Pharmaceuticals Inc. expressed surprise and disappointment after receiving a complete response letter (CRL) late Tuesday from the FDA for investigational drug Probuphine, a subdermal implant designed for the maintenance treatment of opioid dependence in adults. The reaction may have been warranted, however. At first blush, the CRL appeared to have all the trappings of an ambush.

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