Source: https://www.federalregister.gov/articles/2012/12/31/2012-31397/new-animal-drugs-enrofloxacin-melengestrol-meloxicam-pradofloxacin-tylosin
Timestamp: 2015-11-30 17:01:02
Document Index: 115590027

Matched Legal Cases: ['arts 520', 'arts 520', '§ 520', '§ 520', '§ 522', '§ 522', 'art 529', '§ 529', '§ 529', '§ 510', 'art 558', '§ 558', '§ 510']

Federal Register | New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin
New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin
Dates: This rule is effective December 31, 2012.
-76864 (3 pages)
Document Number: 2012-31397
Shorter URL: https://federalregister.gov/a/2012-31397 Regulations.gov Docket Info
Table 1—Original and Supplemental NADAs and ANADAs Approved During November 2012
FDA is amending the animal drug regulations to reflect original and supplemental approval actions during November 2012, as listed in table 1 of this document. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents 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. Persons with access to the Internet may obtain these documents at the Center for Veterinary Medicine FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
Table 1—Original and Supplemental NADAs and ANADAs Approved During November 2012 Back to Top
Original approval for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis,
S. aureus, S. felis, and S. pseudintermedius
520.1860
Abbott Laboratories, Inc., North Chicago, IL 60064
OROCAM (meloxicam) Transmucosal Oral Spray
Original approval for the control of pain and inflammation associated with osteoarthritis in dogs
141-068
BAYTRIL 100 (enrofloxacin) Injectable Solution
Supplemental approval adding treatment and control of swine respiratory disease associated with Bordetella bronchiseptica and Mycoplasma hyopneumoniae
Huvepharma AD, 5th Floor, 3A Nikolay Haitov St., 1113 Sophia, Bulgaria
TYLOVET 100 (tylosin phosphate) and RUMENSIN (monensin) and MGA (melengestrone acetate) liquid and dry, combination drug Type C medicated feeds
Original approval as a generic copy of NADA 138-870
21 CFR Parts 520, 522, and 529
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 520, 522, 529, and 558 are amended as follows:
2.Add § 520.1860 to read as follows: § 520.1860 Pradofloxacin.
(a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) pradofloxacin.
(d) Conditions of use in cats—(1) Amount. Administer 3.4 mg/lb (7.5 mg/kg) body weight once daily for 7 consecutive days.
(2) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis,
Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius.
4.In § 522.812, revise paragraph (e)(3)(ii) to read as follows: § 522.812 Enrofloxacin.
(ii) Indications for use. For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida,
Haemophilus parasuis, Streptococcus suis,
Bordetella bronchiseptica, and Mycoplasma hyopneumoniae.
5.The authority citation for 21 CFR part 529 continues to read as follows: Authority:
6.Add § 529.1350 to read as follows: § 529.1350 Meloxicam.
(b) Sponsor. See No. 000074 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 0.1 mg per kilogram of body weight once daily using the metered dose pump.
7.The authority citation for 21 CFR part 558 continues to read as follows: Authority:
8.In § 558.342, in the table, in paragraph (e)(1)(xi), in the “Limitations” column, revise the last sentence to read “Monensin provided by No. 000986 and tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.”; and in the “Sponsor” column, add “016592”. end regulatory text
[FR Doc. 2012-31397 Filed 12-28-12; 8:45 am]