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US Attorney's Office subpoenas Salix over sales practices for three of its drugs

Salix Pharmaceuticals has received a subpoena from the U.S. Attorney's Office for the Southern District of New York requesting documents related to the Raleigh company's sales and promotional practices for three of its drugs.

The company received the subpoena on Feb. 1, according to a regulatory filing Salix filed Tuesday.

The drugs involved include Salix's best selling drug, Xifaxan, as well as Relistor and Apriso.

Salix said in its filing that it is in the process of responding to the subpoena and intends to cooperate fully with the investigation.

"The company cannot predict or determine the impact of this inquiry on our financial condition or results of operations," the company said in its filing.

Michael Freeman, a Salix spokesman, said Wednesday that the company would have no comment beyond what was in its regulatory filing.

FDA grants Salix drug priority review

The Food and Drug Administration has agreed to give a priority review to Salix Pharmaceutical's potential treatment for HIV-associated diarrhea.

The Raleigh company announced this morning that the FDA has set a June 5 target for making its decision on whether or not to approve the drug.

The FDA grants priority reviews to drugs that offer major advances in treatment or which provide treatment where no adequate therapy exists.

Salix submitted the drug, crofelemer, to the FDA for review in December.  Crofelemer are 125 mg tablets used to treat diarrhea in patients with HIV or AIDS who are on anti-retroviral therapy.

Salix estimates that some 150,000 patients on the therapy experience chronic diarrhea which can cause weight loss and complicate treatment.

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