VI. AGENCY CONCLUSIONS:
The data submitted in support of this NADA satisfy the requirements of section 512 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 514. The data demonstrate that VETSULIN, when used according to the label, is safe and effective for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs and cats with diabetes mellitus.
A. Marketing Status:
This product may be dispensed only by or on the lawful order of a licensed veterinarian (Rx marketing status). Adequate directions for lay use cannot be written because professional expertise is judged to be critical in the diagnosis of diabetes mellitus, management of the condition and monitoring the possible adverse effects of the drug.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act, this approval qualifies for THREE years of marketing exclusivity beginning on the date of the approval. The three years of marketing exclusivity applies only to the new species for which this supplement is approved.
C. Supplemental Applications:
This supplemental NADA required a reevaluation of the safety or effectiveness data in the original NADA (21 CFR §514.106(b)(2)).
D. Patent Information:
The sponsor did not submit any patent information with this application.
Facsimile labeling is attached as indicated below:
Package Insert Owner Information sheet Vial Label (2.5mL and 10 mL) Box Label (2.5 mL and 10 mL)
Ettinger S.J. “Diseases of the endocrine pancreas.” In Textbook of Veterinary Internal Medicine: Disease of the Dog and Cat, 2nd Edition, Philadelphia, PA WB Saunders;