FDA Rejects Drugmaker Move to Narrow NDA Indication

Forest Research Institute tried unsuccessfully to narrow the proposed indication for its chronic obstructive pulmonary disease (COPD) drug candidate Daxas, according to FDA documents made public prior to an advisory committee meeting scheduled for this week. Forest submitted revised product labeling — that narrowed the indication to reduction of exacerbations of COPD — in January after acquiring the NDA from Nycomed late last year. But sponsors’ proposed product indication should be final at the time of NDA submission, the FDA says.
Drug Industry Daily