ARTICLE | Company News

Noven delays NDA

April 2, 2001 7:00 AM UTC

NOVN said that an NDA for its transdermal methylphenidate to treat attention deficit hyperactivity disorder (ADHD) will be delayed by 6-12 months, following a preliminary analysis of the company's Phase III study. The company said one aspect of the Phase III study, which was unblinded in late March, was unsuccessful and that a further clinical trial may be necessary. The company had hoped to make a submission late this quarter. NOVN now expects to meet with the FDA in the second half of April. NOVN was off 9.188 (32%) to $19.125 on Monday. ...