PDF《VeroScience, LLC》

0 to

9 years (inclusive) because necessary studies are impossible or highly impractical (there are too few children in this age range with type

2 diabetes mellitus to study). We are deferring pediatric studies for ages

10 to

16 years (inclusive) for this application because this product is ready for approval for use in adults and the pediatric studies have not been completed. Your deferred pediatric studies required by section 505B(a) of the Federal Food, Drug, and Cosmetic Act are required postmarketing studies. The status of these postmarketing studies must be reported annually according to

21 CFR 314.81 and section 505B(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. These required studies are listed below. 1. Deferred pediatric bioavailability study: To Assess the Safety, Tolerability and Pharmacokinetics of Cycloset in

10 to

16 year old Type

2 Diabetic Subjects Final Protocol Submission Date: No later than December 31,

2009 Study Completion Date: No later than August 31,

2010 Final Study Report Submission Date: No later than October 31,

2010 NDA 20-866 Page

3 2. Deferred pediatric feasibility study: A Randomized, Double-Blind, Controlled Study To Assess the Use and Effectiveness of Cycloset in Children Aged

10 to

16 With a Diagnosis of Type

2 Diabetes Mellitus Final Protocol Submission Date: No later than November 30,

2010 Study Completion Date: No later than October 31,

2012 Final Study Report Submission Date: No later than March 31,

2013 3. Deferred clinical efficacy and safety study: A Pivotal, Randomized, Double-Blind, Controlled, Efficacy and Safety Study of the Use of Cycloset for the Treatment of Type

2 Diabetes Mellitus in Children Aged

10 C

16 years with a Diagnosis of Type

2 Diabetes Mellitus Final Protocol Submission Date: No later than August 31,

2013 Study Completion Date: No later than February 28,

2015 Final Study Report Submission Date: No lat........