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The developer of prescription drugs for the treatment of gastrointestinal disorders received the Complete Response Letter on March 7 for its supplemental New Drug Application for Xifaxan.
The letter primarily covered a newly expressed need for retreatment, according to Salix, which lost a quarter of its value on Feb. 24 when it indicated the possibility of a letter. Complete response letters typically mean the agency believes the drug is not ready for approval.
Salix said it intends to meet with the agency to discuss the drug within 30 days, though the company said in a statement it “cannot begin to formulate future development plans” for IBS.
There are currently other prescription drugs available in the U.S. for IBS.
Xifaxan was approved by the FDA in 2004 for traveler’s diarrhea and won approval last March for reducing the risk of a brain disorder in adults with chronic liver failure.