DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208159/S-01 SUPPLEMENT APPROVAL Wellstat Therapeutics Attention: Michael K. Bamat, PhD 930 Clopper Rd. Gaithersburg, MD 20878 Dear Dr. Bamat: Please refer to your Supplemental New Drug Application (sNDA) dated January 7, 2016, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Vistogard® (uridine triacetate) Oral Granules. This Prior Approval supplemental new drug application provides for: 1. Changes to the logo, color and font of the carton and container. 2. Editorial corrections to the wording of the carton and container. APPROVAL & LABELING We have completed our review of this supplemental application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text. CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate 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 Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (June 2008). Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or similar material. For administrative purposes, designate this submission “Final Printed Carton and Container Labels for approved NDA 208159/S-01.” Approval of this submission by FDA is not required before the labeling is used. Marketing the product(s) with FPL that is not identical to the approved labeling text may render the product misbranded and an unapproved new drug. Reference ID: 3909309 NDA 208159/S-01 Page 2 REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). If you have any questions, call Jeannette Dinin, Regulatory Project Manager, at (240) 402-4978 or email: Jeannette.Dinin@fda.hhs.gov. Sincerely, {See appended electronic signature page} Geoffrey Kim, MD Director Division of Oncology Products 1 Office of Hematology and Oncology Products Center for Drug Evaluation and Research ENCLOSURE(S): Carton and Container Labeling Reference ID: 3909309 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------/s/ ---------------------------------------------------GEOFFREY S KIM 03/29/2016 Reference ID: 3909309 (