Salix Pharmaceuticals [NASDAQ:SLXP] has NDA declined by the FDA

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Salix Pharmaceuticals [NASDAQ:SLXP] has NDA declined by the FDA

Companies - Biotechnology Companies

Written by Hugh McManus

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Thursday, 29 April 2010 07:35

Salix Pharmaceuticals, which closed at $38.78, has had a rollercoaster year. The FDA issued a response letter to the NDA for GIAZO (balsalazide disodium) tablets. The agency found deficiencies in the manufacturing facility. Given that the API has been around for a while, a manufacturing failure is surprising.

The news is bad, but certainly not crippling, for Salix. On December 30, 08, the agency demanded more clinical trial data. At least in this review, the FDA didn't ask for that more trials.

I am digging into this issue to try and find out what exactly is happening. The FDA has now turned down two recent applications for problems in manufacturing. I have contacted Salix to try and get more information. I will keep you posted.

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