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
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.