PDUFA Date Set For Tomorrow February 23 (NASDAQ:SLXP)

On August 24, 2009, Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) disclosed that the FDA had found that new drug application (NDA) – that was submitted for the company’s recently developed rifaximin tablets 550 mg – contained  all the information that would allow it to make a thorough review – that is, the NDA was accepted for filing. The FDA also decided to start the Priority Review of the NDA. The regulator also handed out a Prescription Drug User Fee Act date – also called Action date or just PDUFA date – of December 24, 2009. This was the date on which the FDA was expected to complete the Priority Review and to provide a response on the NDA to Salix. However, the company later confirmed that the FDA had extended the PDUFA date to February 23, 2010.

@@CalendarRight@@ This decision to delay the PDUFA date of rifaxim – a drug used for the “maintenance of remission of hepatic encephalopathy (HE)” – was made by an Advisory Committee of the FDA.

Right after the news of the NDA filinf, Bill Forbes, Pharm.D., who is the Chief Development Officer (CDO) and also the Senior Vice President of Salix Pharmaceuticals, said:

“We are pleased with the FDA’s acceptance for filing of the rifaximin NDA and their decision to grant Priority Review for our application. This review classification signals that the FDA considers that rifaximin has the potential to provide a significant advance in the treatment of hepatic encephalopathy. We are not surprised at the FDA’s decision to convene an Advisory Committee to gain an independent recommendation from outside experts regarding rifaximin due to the fact that, if approved, rifaximin will be the first new option approved for the management of HE in over 30 years. We believe the availability of rifaximin has the potential to change the treatment paradigm for HE. Today’s news marks a milestone for Salix, rifaximin and patients suffering from this serious condition.”