Exhibit 99.1
NDA 22180/S-009
DEFICIENCIES PRECLUDE DISCUSSION
Amag Pharmaceuticals, Inc.
Attention: Steve Caffé, MD
Chief Development and Regulatory Affairs Officer
100 Hayden Ave
Lexington, MA 02152
Dear Dr. Caffé:
Please refer to your December 21, 2012 Supplemental New Drug Application (sNDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Feraheme® (ferumoxytol) Injection, 510 mg.
We also refer to our March 5, 2013, letter in which we notified you of our target date of September 23, 2013 for communicating labeling changes and/or postmarketing requirements/commitments in accordance with the “PDUFA Reauthorization Performance Goals And Procedures – Fiscal Years 2008 Through 2012.”
As part of our ongoing review of your supplemental application, we have identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.
This notification does not reflect a final decision on the information under review.
If you have any questions, call Jessica Boehmer, Regulatory Project Manager, at (301) 796-5357.
| Sincerely, |
| |
| {See appended electronic signature page} |
| |
| Kathy Robie Suh, M.D., Ph.D. |
| Clinical Team Leader |
| Division of Hematology Products |
| Office of Hematology and Oncology Products |
| Center for Drug Evaluation and Research |
Reference ID: 3377552
This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. |
/s/
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KATHY M ROBIE SUH
09/23/2013
Reference ID: 3377552
