Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
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On 6/30/09, AMAG Pharma (NASDAQ:AMAG) announced that the FDA has granted marketing approval for Feraheme (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. The recommended dose of Feraheme is an initial 510 mg IV injection followed by a second 510 mg IV injection three to eight days later. Feraheme should be administered as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec).
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The recommended Feraheme dose may be re-administered to patients with persistent or recurrent iron deficiency anemia. Feraheme is expected to be commercially available in the U.S. during the second half of July 2009. Feraheme will be distributed primarily through wholesalers and specialty distributors. The Company will market and sell Feraheme through its commercial organization consisting of approximately 150 seasoned professionals, including an 80-person specialized sales force, an experienced account management and reimbursement team, and a contract nurse team.
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The FDA approval of Feraheme was based on safety and efficacy results from four Phase 3 studies of patients with chronic kidney disease and iron deficiency anemia. These studies consisted of three open label, multi-center, randomized safety and efficacy clinical studies and a fourth double-blind, multi-center, randomized, placebo-controlled cross-over safety study. Each of the three pivotal safety and efficacy studies achieved statistical significance in its primary endpoint: the mean change in hemoglobin from baseline at Day 35 after the first dose.
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Feraheme significantly increased hemoglobin levels as compared to oral iron across the spectrum of chronic kidney disease. Overall, 1,726 subjects were exposed to Feraheme in the development program, including 1,562 patients with all stages of chronic kidney disease. In accordance with the Pediatric Research Equity Act (PREA) requirement, the Company will conduct two post-marketing studies in the pediatric chronic kidney disease population; one in patients on dialysis and the other in patients not on dialysis. Each study will enroll approximately 75 subjects, collecting pharmacokinetic, safety and efficacy data as compared to oral iron. The Company expects to commence these studies in 2010.
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Disclosure: Long AMAG.
$54.67 (06/30/09)
