Sandoz sues FDA seeking Omnitrope decision

Sandoz filed a lawsuit against FDA and HHS in the U.S. District Court for the District of Columbia seeking an order compelling FDA to act on an application for Omnitrope, a follow-on version of human growth hormone (hGH). The suit also asks the court to rule that FDA must create a pathway for the approval of follow-on versions of protein-based biologics that are regulated as drugs. The suit asserts that FDA has raised no scientific or medical objections to the Omnitrope NDA, that the product is "indistinguishable" from Genotropin hGH from Pfizer (PFE), and that Sandoz is not seeking to have its product classified as interchangeable with Genotropin. ...