21 Cfr Part 522 – Federal Register Recent Federal Regulation Documents

Implantation or Injectable Dosage Form New Animal Drugs; Insulin
Document Number: E9-29583
Type: Rule
Date: 2009-12-14
Agency: Food and Drug Administration, Department of Health and Human Services, 21 Cfr Part 522
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for veterinary prescription use of an injectable suspension of protamine zinc recombinant human insulin for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.