Holzkirchen, Germany-based Sandoz, the generics division of Switzerland’s largest drugmaker Novartis, has filed a lawsuit against the US Food and Drug Administration seeking a ruling on its pending New Drug Application for Omnitrope, a human growth hormone.
The company filed its application in July 2003 and, in September last year, the group reported the Agency’s notification of failure to reach a decision on the NDA for the drug. The lawsuit, which was filed in US District Court for the District of Columbia, aims to reverse the FDA’s failure to act on the Omnitrope application, in accordance with the Commissioner’s statutory obligations, the group explained.
Andreas Rummelt. Sandoz’ chief executive, stated that the firm believes “it is important for patients and healthcare providers that cost-effective follow-on protein products like Omnitrope become available as safe and effective, but less expensive and equivalent therapeutic alternatives.” He went on to predict that, “having already acknowledged the sound science behind this application, the FDA should approve Omnitrope.”