[Federal Register: May 1, 1998 (Volume 63, Number 84)] [Rules and Regulations] [Page 24105-24106] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01my98-3] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 529 Certain Other Dosage Form New Animal Drugs; Isoflurane 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 an abbreviated new animal drug application (ANADA) filed by Marsam Pharmaceuticals, Inc. The ANADA provides for inhalational use of isoflurane USP for induction and maintenance of general anesthesia in horses and dogs. EFFECTIVE DATE: May 1, 1998. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209. SUPPLEMENTARY INFORMATION: Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., Cherry Hill, NJ 08034, filed ANADA 200-187 that provides for inhalational use of isoflurane USP for induction and maintenance of general anesthesia in horses and dogs. The drug is limited to use by or on the order of a licensed veterinarian. Approval of ANADA 200-187 for Marsam Pharmaceuticals, Inc.'s, isoflurane is as a generic copy of Ohmeda Pharmaceutical Product's NADA 135-773 AErrane (isoflurane, USP). The ANADA is approved as of February 11, 1998, and the regulations are amended in 21 CFR 529.1186(b) to reflect the approval. The basis of approval is discussed in the freedom of information summary. In addition, Marsam Pharmaceuticals, Inc., has not been previously listed in Sec. 510.600 (21 CFR 510.600) as sponsor of an approved application. The regulations are amended in Sec. 510.600(c)(1) and (c)(2) to reflect the new sponsor. 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 20855, 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. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 529 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 529 are amended as follows: PART 510--NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: [[Page 24106]] Authority: 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 an entry for ``Marsam Pharmaceuticals, Inc.,'' and in the table in paragraph (c)(2) by numerically adding an entry for ``000209'' 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 ---------------------------------------------------------------------------------------------------------------- * * * * * * * Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., 000209 Cherry Hill, NJ 08034. * * * * * * * ---------------------------------------------------------------------------------------------------------------- (2) * * * ---------------------------------------------------------------------------------------------------------------- Drug labeler code Firm name and address ---------------------------------------------------------------------------------------------------------------- * * * * * * * 000209 Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., Cherry Hill, NJ 08034. * * * * * * * ---------------------------------------------------------------------------------------------------------------- PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 529 continues to read as follows: Authority: 21 U.S.C. 360b. 2. Section 529.1186 is amended by revising paragraph (b) to read as follows: Sec. 529.1186 Isoflurane. * * * * * (b) Sponsors. See Nos. 000074, 000209, 010019, 012164, and 059258 in Sec. 510.600(c) of this chapter. * * * * * Dated: April 22, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 98-11685 Filed 4-30-98; 8:45 am] BILLING CODE 4160-01-F