FDA notified Takeda Pharmaceutical and Forest Laboratories along with Cypress Bioscience that it will not be able to take final action by the scheduled PDUFA action date for their respective NDAs. Additionally, Amag Pharmaceuticals received a complete response letter related to its anemia drug.
Amag submitted the NDA covering the use of ferumoxytol to treat iron deficiency anemia in chronic kidney disease patients in December 2007. The firm doesn’t believe that the requirements detailed in the complete response letter will affect its planned launch in the first quarter of 2009. Amag adds that no further clinical trials are necessary to address the agency’s issues. No one was immediately available to comment on the details of the complete response letter.
Separately, FDA reports that it will need another three months to complete the review of TAK-390MR, Takeda’s treatment for GERD and erosive esophagitis. It is designed as a once-daily, oral treatment of daytime and nighttime heartburn and other symptoms of GERD, the healing of erosive esophagitis, and the maintenance of healed erosive esophagitis. The NDA was filed in December 2007.
Similarly, the agency also delayed review of milnacipran, which Forest and Cypress Bioscience developed for the management of fibromyalgia. Milnacipran is a selective serotonin and norepinephrine reuptake inhibitor.
The original date was set for October 18, but the FDA now says that will need a few more weeks to complete the review. The agency could not confirm a specific date or reason for the delay, according to the companies.
FDA has not requested any additional information but does require confirmation on a question related to the clinical data. The firms continue to plan for a first quarter 2009 product launch meeting.