April 30 (Reuters) – Salix Pharmaceuticals Ltd said
U.S. health regulators have extended the review date by three
months for its experimental pill for HIV therapy-related
diarrhea.
The U.S. Food and Drug Administration was to review the
drug, crofelemer, on June 5.
The FDA has notified Salix that it requires additional time
for a full review but did not seek any additional studies, the
company said in a statement.
Salix holds the North American and European rights to the
drug.
India’s Glenmark Pharmaceuticals Ltd holds the
rights to sell the drug in 140 other countries but is in
arbitration to retain them after initial developer U.S.-based
Napo Pharamaceuticals Inc terminated their agreement in
November.
Shares of Salix Pharmaceuticals were trading down about 3
percent at $49.28 on Monday afternoon trade on the Nasdaq.
