Source: https://www.federalregister.gov/documents/2004/08/05/04-17876/implantation-or-injectable-dosage-form-new-animal-drugs-romifidine
Timestamp: 2018-03-24 14:21:16
Document Index: 578467058

Matched Legal Cases: ['art 522', '§\u2009522', 'art 20', 'art 522', '§\u2009522', '§\u2009510']

Federal Register :: Implantation or Injectable Dosage Form New Animal Drugs; Romifidine
Implantation or Injectable Dosage Form New Animal Drugs; Romifidine
A Rule by the Food and Drug Administration on 08/05/2004
This rule is effective August 5, 2004.
69 FR 47362
47362-47363 (2 pages)
04-17876
https://www.federalregister.gov/d/04-17876 https://www.federalregister.gov/d/04-17876
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of romifidine hydrochloride injectable solution in horses as a sedative and analgesic, and as a preanesthetic agent.
Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: mberson@cvm.fda.gov.
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-229 that provides for the veterinary prescription use of SEDIVET (romifidine hydrochloride) 1% Injection as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedures, and minor surgical procedures in adult horses. SEDIVET 1% Injection is also indicated as a preanesthetic to the induction of general anesthesia in adult horses. The NADA is approved as of June 3, 2004, and 21 CFR part 522 is amended by adding § 522.2076 to reflect the approval. The basis of approval is discussed in the freedom of information summary.
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 Start Printed Page 47363may 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.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning .
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:
2. Section 522.2076 is added to read as follows:
§ 522.2076
Romifidine.
(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) romifidine hydrochloride.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in horses—(1) Amount. 40 to 120 micrograms per kilogram of body weight (mcg/kg BW) intravenously for sedation and analgesia; 100 mcg/kg BW intravenously as a preanesthetic.
(2) Indications for use. For use as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedures, and minor surgical procedures in adult horses; and for use as a preanesthetic prior to the induction of general anesthesia in adult horses.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for horses intended for human consumption
[FR Doc. 04-17876 Filed 8-4-04; 8:45 am]