Novartis responds to Pfizer hGH petition

NVS subsidiary Sandoz responded to a citizen petition that PFE submitted to FDA in May, and accused PFE of misappropriating and improperly publicizing Sandoz's data as part of an effort to derail an application for Omnitrop generic human growth hormone (hGH). In its petition, PFE contended that it would be impossible for FDA to review the Omnitrop application without improperly relying on PFE's trade secrets (see BioCentury, May 17, 2004). PFE also attached a Sandoz draft trial protocol to its petition and cited the draft protocol as evidence that Omnitrop cannot be approved based on comparisons to PFE's Genotropin hGH because, PFE alleged, the two products have significantly different molecular weights. ...