RALEIGH, N.C. (AP) -- Salix Pharmaceuticals Inc. said Wednesday the Food and Drug Administration is withholding approval of an ulcerative colitis drug because of potential manufacturing deficiencies.
The company received a letter from the FDA raising the manufacturing deficiency issues for the facility where Giazo is made. The drug is aimed at treating mild to moderate forms of the inflammatory bowel disease in adults.
The FDA is not asking for new studies on the drug and the issue is solely with the manufacturing facility, the company said. The company did not provide detail on the manufacturing facility or the deficiencies.
The manufacturer has responded to the FDA and is working with the agency, Salix said.
Shares of Salix rose 1 cent to $38.56 in midday trading.
