NDA 21-649
Ms. Nancy L. Buc
Ms. Deborah Livornese
Buc & Beardsley
919 Eighteenth Street, N.W. Washington, D.C. 20006-5503

Dear Ms. Buc and Ms. Livornese:

We wrote to you on October 22, 2007, indicating that we would need additional time to complete our response to your complaint and request for correction (received on May 15, 2007) and complaint amendment (received on June 26, 2007) pursuant to the Information Quality Act.

While our goal is to respond within 60 days to such Information Quality Act requests, we are unable to do so in this case. We anticipate that a response will be forwarded to you within 60 days from the date of this letter.

Sincerely,

John K. Jenkins, M.D., F.C.C.P.
Director
Office of New Drugs
Center for Drug Evaluation and Research
Food and Drug Administration

cc: Jane Axelrad
Laurie Lenkel
Gerald Masoudi

This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
/s/

John Jenkins
12/19/2007 04:42:58 PM