FDA delays decision on Salix's diarrhea drug

Wed Sep 5, 2012 7:58am EDT

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(Reuters) - Salix Pharmaceuticals Ltd said the U.S. Food and Drug Administration would take more time to review the drugmaker's new treatment for HIV-related diarrhea and it now expects a regulatory decision by the end of the first quarter of 2013.

The drug crofelemer aims to provide symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy.

The FDA had earlier set Wednesday as the day to complete the review on the Salix drug.

"By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue," Salix's Chief Development Officer Bill Forbes said in a statement.

Salix and the FDA were primarily discussing the production and control of the crofelemer active pharmaceutical ingredient - "a complex mixture that is the first botanical product to be reviewed by the agency for oral use."

About 1.2 million people in the United States are living with HIV/AIDS and about 40 percent of those patients suffer from either episodic or chronic diarrhea, Salix said.

Salix shares closed at $43.95 on Tuesday on the Nasdaq.

(Reporting by Esha Dey in Bangalore; Editing by Rodney Joyce)

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