FDA files Omnitrope motion

FDA rejected the arguments and assertions Sandoz made in litigation over the agency's review of Omnitrope somatropin, a follow-on version of human growth hormone (hGH). In a motion filed late Monday in the U.S. District Court for the District of Columbia, the government said that Sandoz has asked the court to declare FDA's evaluation "to be a sham and to find the safety and efficacy of Omnitrope to be self-evident." The government also asserted that there is no legal basis for forcing FDA action on Omnitrope and that "facts Sandoz wants this Court to adopt in order to rule in its favor are pulled out of thin air." The government asked the court to deny Sandoz's request for a judgment compelling FDA to act on the Omnitrope application.

The government also accused Sandoz of quoting comments made by a judge in an unrelated case out of context. Last week, the generics unit of Novartis (NVS; SWX:NOVN) filed documents comparing FDA's lack of action on the Omnitrope NDA to the agency's protracted review of an application from Barr (BRL) to market Plan B levonorgestrel emergency contraceptive over the counter. FDA reiterated its position that the Omnitrope review is ongoing (see BioCentury Extra, Wednesday Feb. 22, 2006). ...