[Federal Register Volume 62, Number 124 (Friday, June 27, 1997)] [Rules and Regulations] [Pages 34631-34632] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-16791] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520 Animal Drugs, Feeds, and Related Products; Selegiline Hydrochloride Tablet 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 new animal drug application (NADA) filed by Deprenyl Animal Health, Inc. The NADA provides for oral use of selegiline hydrochloride tablets for dogs for the control of clinical signs associated with uncomplicated pituitary-dependent hyperadrenocorticism. EFFECTIVE DATE: June 27, 1997. FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center For Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-0614. SUPPLEMENTARY INFORMATION: Deprenyl Animal Health, Inc., 7101 College Blvd., suite 580, Overland Park, KS 66210, filed NADA 141-080, which provides for oral use of Anipryl(selegiline hydrochloride) tablets for dogs for the control of clinical signs associated with uncomplicated pituitary-dependent hyperadrenocorticism. The drug is limited to use by or on the order of a licensed veterinarian. The NADA is approved as of May 30, 1997, and the regulations are amended by adding new 21 CFR 520.2098 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In addition, Deprenyl Animal Health, Inc., has not previously been listed in the animal drug regulations as the sponsor of an approved application. At this time, 21 CFR 510.600(c) is amended to add listings for the firm. In accordance with the freedom of information provisions of 21 CFR part 20 and 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 Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. to 4 p.m., Monday to Friday. Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning May 30, 1997, because no active ingredient of the drug, including any ester or salt of the active ingredient, has been approved in any other application. FDA has carefully considered the potential environmental effects of this action and has concluded that this action will not have a significant impact on the human environment, and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (see above). List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 520 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 parts 510 and 520 are amended as follows: PART 510--NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e). 2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding a new entry for ``Deprenyl Animal Health, Inc.''and in the table in paragraph (c)(2) by numerically adding a new entry for ``063248'' to read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Firm name and address Drug labeler code ---------------------------------------------------------------------------------------------------------------- * * * * * * * Deprenyl Animal Health, Inc., 7101 College Blvd., suite 063248 580, Overland Park., KS 66210. * * * * * * * ---------------------------------------------------------------------------------------------------------------- (2) * * * ---------------------------------------------------------------------------------------------------------------- Drug labeler code Firm name and address ---------------------------------------------------------------------------------------------------------------- * * * * * * * 063248 Deprenyl Animal Health, Inc., 7101 College Blvd., suite 580, Overland Park, KS 66210. * * * * * * * ---------------------------------------------------------------------------------------------------------------- [[Page 34632]] PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). 4. New Sec. 520.2098 is added to read as follows: Sec. 520.2098 Selegiline hydrochloride tablets. (a) Specifications. Each tablet contains either 2, 5, 10, 15, or 30 milligrams of selegiline hydrochloride. (b) Sponsor. See No. 063248 in Sec. 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use-- (1) Dosage. 1 milligram per kilogram (0.45 milligram per pound) of body weight. (2) Indications for use. For control of clinical signs associated with uncomplicated pituitary-dependent hyperadrenocorticism. (3) Limitations. Administer orally once daily. If no improvement in clinical signs or physical examination findings after 2 months of therapy, increase dose to a maximum of 2 milligrams per kilogram once daily. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: June 16, 1997. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 97-16791 Filed 6-26-97; 8:45 am] BILLING CODE 4160-01-F