Feb 4 The U.S. Food and Drug Administration rejected a migraine drug made by Israel's RedHill Biopharma Ltd and Canada's IntelGenx Corp.
The FDA raised questions about the third-party manufacturing process, as well as the packaging and labeling of the drug, called RHB-103, the companies said in a statement.
The FDA's concerns were laid out in a complete response letter, which is a list of FDA concerns that need to be addressed before a medicine is approved.
The companies said the FDA did not raise any questions about the drug's safety, which means the drug does not require additional clinical studies.
"We believe that the questions raised by the FDA can be addressed based on available data, and we plan to work vigorously to submit our response within a few weeks," the companies said.
RedHill's U.S.-listed shares fell almost 3 percent to $13.02 in trading before the bell on Tuesday. IntelGenx shares closed at C$1.07 on Monday.