E9-30222. Implantation or Injectable Dosage Form New Animal Drugs; Polysulfated Glycosaminoglycan

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 Luitpold Pharmaceuticals, Inc. The supplemental NADA provides for additional vial sizes for an injectable solution of polysulfated glycosaminoglycan.

DATES:

This rule is effective December 21, 2009.

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:

Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967, filed a supplement to NADA 140-901 for ADEQUAN (polysulfated glycosaminoglycan), an injectable solution approved for use in horses and dogs by veterinary prescription for noninfectious degenerative and/or traumatic joint disease. The supplemental NADA provides for additional vial sizes. The application is approved as of November 10, 2009, and the regulations are amended in 21 CFR 522.1850 to reflect the approval.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

The agency has determined under § 25.33 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.

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 § 522.1850, revise paragraph (a) to read as follows:

§ 522.1850

Polysulfated glycosaminoglycan.

(a) Specifications. (1) Each 1-milliliter (mL) ampule of solution contains 250 milligrams (mg) polysulfated glycosaminoglycan.

(2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-mL vials contains 100 mg polysulfated glycosaminoglycan.

Dated: December 15, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.