Letter from FDA Director to Amylin's (AMLN) Kolterman Discussing Bydureon Approval
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Summary of letter from Mary Parks, M.D., Director of the FDA's Division of Metabolism and Endrocrinolgoy Products, to Amylin (Nasdaq: AMLN):
Amylin Pharmaceuticals, Inc.
Orville Kolterman, M.D.
Sr. Vice President, Research & Development
9360 Towne Centre Drive, Suite 110
San Diego, CA 92121
Dear Dr. Kolterman:
Please refer to your new drug application (NDA) submitted on May 4, 2009 and received May 5, 2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for BYDUREON (exenatide extended-release for injectable suspension).
We acknowledge receipt of your amendments dated July 28, August 15, 16, 25, September 22, October 4, 20, 24, November 3, and December 8, 2011, and January 10 and 24, 2012.
The July 28, 2011, submission constituted a complete response to our October 18, 2010, action letter.
This new drug application provides for the use of BYDUREON (exenatide extended-release for injectable suspension) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.
We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
Amylin Pharmaceuticals, Inc.
Orville Kolterman, M.D.
Sr. Vice President, Research & Development
9360 Towne Centre Drive, Suite 110
San Diego, CA 92121
Dear Dr. Kolterman:
Please refer to your new drug application (NDA) submitted on May 4, 2009 and received May 5, 2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for BYDUREON (exenatide extended-release for injectable suspension).
We acknowledge receipt of your amendments dated July 28, August 15, 16, 25, September 22, October 4, 20, 24, November 3, and December 8, 2011, and January 10 and 24, 2012.
The July 28, 2011, submission constituted a complete response to our October 18, 2010, action letter.
This new drug application provides for the use of BYDUREON (exenatide extended-release for injectable suspension) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.
We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
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