PDF《VeroScience, LLC》

DEPARTMENT OF HEALTH &

HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD

20857 NDA 20-866 NDA APPROVAL VeroScience, LLC Attention: Anthony H.

Cincotta, Ph.D. President and Chief Scientific Officer

1334 Main Road Tiverton, RI

02878 Dear Dr. Cincotta: Please refer to your new drug application (NDA) dated August 22, 1997, received August 22, 1997, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Cycloset (bromocriptine mesylate) tablets, 0.8 mg. We acknowledge receipt of your submissions dated April

9 and July 12, 2002, April

2 and November 24, 2003, March 4, 5, and 19, May

27 and July 12, 2004, May

16 (2) and December 21, 2006, January 11, March 9, June 1, and December 12, 2007, March 7, April 13, June

25 (2), August 4, September 4, 19, and 24, October 6,

8 (2), and

9 (2), November

12 and 24, and December 26, 2008, and January

5 and 21, February 16, March

3 and 10, April 13, and May 1, 2009. The April 13, 2008, submission constituted a complete response to our October 15, 1999, action letter. This new drug application provides for the use of Cycloset as an adjunct to diet and exercise to improve glycemic control in adults with type

2 diabetes mellitus. 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 (text for the package insert and patient counseling information submitted May 4, 2009, and carton and container labels submitted December 26, 2008). CONTENT OF LABELING As soon as possible, but no later than

14 days from the date of this letter, please submit the content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format as described at http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed labeling (text for the package insert and patient counseling information). Upon receipt, we will transmit that version to the National Library of Medicine for public dissemination. For administrative purposes, please designate this submission, SPL for approved NDA 20-866. NDA 20-866 Page

2 CARTON AND IMMEDIATE CONTAINER LABELS We acknowledge your December 26, 2008, submission containing printed carton and container labels. Submit final printed carton and container labels that are identical to the enclosed carton and immediate container labels as soon as they are available, but no more than

30 days after they are printed. Please submit these labels electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format C Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (October 2005). For administrative purposes, designate this submission Final Printed Carton and Container Labels for approved NDA 20-866. Approval of this submission by FDA is not required before the labeling is used. Marketing the product with FPL that is not identical to the approved labeling text may render the product misbranded and an unapproved new drug. PEDIATRIC RESEARCH EQUITY ACT (PREA) Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable. We are waiving the pediatric study requirement for ages