12:00 AM
Dec 10, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Amitiza lubiprostone regulatory update

Sucampo said FDA extended by 3 months the PDUFA date for an sNDA for Amitiza lubiprostone to treat opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. The new date for the application, which has Priority Review, is in April 2013; it was in January. According to Sucampo, FDA needs more time...

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