FDA Rejects New Drug for Irritable Bowel Syndrome
At a meeting last year, the FDA's own gastrointestinal drugs
advisory committee said Zelnorm was effective and "did not voice any safety
concerns," the agency's Jason Brodsky tells WebMD.
In addition, the FDA issued an "approvable" letter to
Novartis in August, which stated that the drug could be approved, provided the
company conducted one additional trial to confirm that the drug was safe and
effective. Novartis conducted this trial and thought it had satisfied the FDA's
concerns, Pozarek says.
"It is unusual" for the FDA not to follow the
recommendation of its advisory committees, which consist of independent
experts, Brodsky says, but he declined to offer further insight on why the FDA
Pozarek says Novartis has not decided if it will appeal the