FDA puts Omnitrope on hold

FDA has deferred a decision on the approval of Novartis' Omnitrope generic human growth hormone, pending resolution of scientific and legal issues associated with a regulatory pathway for follow-on proteins. The agency's letter to Novartis subsidiary Sandoz "did not identify any deficiencies in the application," nor did it request additional data, according to Novartis (NVS; SWX:NOVN).

Omnitrope's PDUFA date was Aug. 31. FDA's letter, signed by David Orloff, director of the Division of Metabolic and Endocrine Drug Products at FDA's Center for Drug Evaluation and Research, does not establish a new PDUFA date. Orloff informed Sandoz that FDA does not know when it will resolve the outstanding issues. His letter referenced Citizen Petitions filed by NVS as well as its rivals, Pfizer (PFE) and Genentech (DNA), and noted that the agency has scheduled public meetings on scientific aspects of follow-on proteins on Sept. 14-15 and in early 2005 (see BioCentury, July 5, 2004). ...