The letter was received following the company’s Class 1 resubmission in response to an October 2008 complete response letter. The company believes that no additional clinical trials will be required for approval.
The FDA has indicated in its letter that certain additional information is required prior to granting approval of ferumoxytol – data to clarify a specific chemistry, manufacturing and controls question; resolution of the deficiencies observed during the pre-approval inspection of the company’s manufacturing facility and finalization of labeling discussions with the FDA.
The FDA has also informed the company that Feraheme as the trade name for ferumoxytol is acceptable. The company is pleased with label discussions to date and seeks approval of ferumoxytol for the treatment of iron deficiency anemia in patients with chronic kidney disease, whether or not on dialysis. However, the final label decision rests with the FDA.
Brian Pereira, president and CEO of Amag Pharmaceuticals, said: We will continue to work expeditiously and collaboratively with the FDA to address the issues raised in the complete response letter. We are pleased with the progress that we have made in addressing the observations raised during the pre-approval inspection of our manufacturing facility, and we are fully committed to conducting our manufacturing operations consistent with the highest quality standards.