E8-8347. Implantation or Injectable Dosage Form New Animal Drugs; Insulin

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for the veterinary prescription use of an injectable suspension of porcine insulin zinc for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.

DATES:

This rule is effective April 18, 2008.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Intervet, Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed a supplement to NADA 141-236 providing for the veterinary prescription use of VETSULIN (porcine insulin zinc) Suspension for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus. The application also provides for a lower initial dosage of insulin for dogs. The supplemental NADA is approved as of March 24, 2008, and the regulations are amended in 21 CFR 522.1160 to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act 21 U.S.C 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. The three years of marketing exclusivity applies only to the indication for use in cats for which this supplement is approved.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

• Animal drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. In § 522.1160, revise paragraphs (a) and (c) to read as follows:

§ 522.1160

Insulin.

(a) Specifications. Each milliliter of porcine insulin zinc suspension contains 40 international units (IU) of insulin.

* * * * *

(c) Conditions of use—(1) Dogs—(i) Amount. Administer an initial once-daily dose of 0.5 IU per kilogram of body weight by subcutaneous injection concurrently with or right after a meal. Adjust this once-daily dose at appropriate intervals based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained. Twice-daily therapy should be initiated if the duration of insulin action is determined to be inadequate. If twice-daily treatment is initiated, the two doses should be 25 percent less than the once daily dose required to attain an acceptable nadir.

(ii) Indications for use. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. Administer an initial dose of 1 to 2 IU by subcutaneous injection. Injections should be given twice daily at approximately 12-hour intervals. For cats fed twice daily, the injections should be concurrent with or right after a meal. For cats fed ad libitum, no change in feeding is needed. Adjust the dose at appropriate intervals based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained.

(ii) Indications for use. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: April 4, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.