Source: https://www.federalregister.gov/articles/2012/08/09/2012-19498/new-animal-drugs-cephalexin-fentanyl-milbemycin-oxime-and-praziquantel
Timestamp: 2015-10-05 18:50:28
Document Index: 710830672

Matched Legal Cases: ['§ 510', '§ 510', '§ 520', '§ 510', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 520', '§ 510', 'art 524', '§ 524', '§ 524', '§ 510']

Federal Register | New Animal Drugs; Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel
Dates: This rule is effective August 9, 2012.
-47512 (2 pages)
Document Number: 2012-19498
Shorter URL: https://federalregister.gov/a/2012-19498 Related Topics
Table 1—Original and Supplemental NADAs and ANADAs Approved During June 2012 Back to Top
1The agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment (EA) or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
Original approval for the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius
New 520.376
Nexcyon Pharmaceuticals, Inc., 644 W. Washington Ave., Madison, WI 53703
RECUVYRA (fentanyl) Transdermal Solution
Original approval for control of postoperative pain associated with surgical procedures in dogs
New 524.916
INTERCEPTOR SPECTRUM (milbemycin oxime/praziquantel) Chewable Tablets
Original approval for prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, and E. granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older
New 520.1445
2.In § 510.600, in the table in paragraph (c)(1), alphabetically add an entry for “Nexcyon Pharmaceuticals, Inc.”; and in the table in paragraph (c)(2), numerically add an entry for “050929” to read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
4.Section 520.376 is added to read as follows: § 520.376 Cephalexin.
(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.
§ 520.1445 [Redesignated as § 520.1441]
§ 520.1446 [Redesignated as § 520.1443]
5.Redesignate §§ 520.1445 and 520.1446 as §§ 520.1441 and 520.1443, respectively. 6.Revise the section heading of newly redesignated § 520.1445 to read as follows: § 520.1441 Milbemycin oxime.
7.Revise the section heading of newly redesignated § 520.1446 to read as follows: § 520.1443 Milbemycin oxime and lufenuron.
8.Add new § 520.1445 to read as follows: § 520.1445 Milbemycin oxime and praziquantel.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
9.The authority citation for 21 CFR part 524 continues to read as follows: Authority:
10.Add § 524.916 to read as follows: § 524.916 Fentanyl.
(b) Sponsor. See No. 050929 in § 510.600(c) of this chapter.