[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Rules and Regulations]
[Pages 74018-74021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29249]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 558
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor; Withdrawal of Approval of New Animal Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule, technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during September and October 2014. FDA is also informing the
public of the availability of summaries of the basis of approval and of
environmental review documents, where applicable. The animal drug
regulations are also being amended to reflect a change of sponsorship
of six NADAs and four ANADAs, the voluntary withdrawal of approval of
an ANADA, and a correcting amendment.
DATES: This rule is effective December 15, 2014, except for the
amendment to 21 CFR 520.1660d, which is effective December 26, 2014.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
[email protected].
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during September and
October 2014, as listed in table 1. 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 CVM FOIA Electronic
Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
In addition, Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601,
has transferred ownership of, and all rights and interest in, the
following approved applications to Akorn Animal Health, Inc., 1925 West
Field Ct., Suite 300, Lake Forest, IL 60045.
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File No. Product name 21 CFR cite
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139-236....................................... ANASED (xylazine hydrochloride) Injectable 522.2662
Solution.
140-866....................................... YOBINE (yohimbine hydrochloride) Injectable 522.2670
Solution.
140-994....................................... TOLAZINE (tolazine hydrochloride) Injectable 522.2474
Solution.
200-055....................................... VETAKET (ketamine hydrochloride) Injectable 522.1222
Solution.
200-332....................................... BUTORPHIC (butorphanol tartrate) Injectable 522.246
Solution.
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Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601,
has transferred ownership of, and all rights and interest in, the
following approved applications to V[eacute]toquinol USA, Inc., 4250 N.
Sylvania Ave., Fort Worth, TX 76137.
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File No. Product name 21 CFR cite
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141-431....................................... FOLLTROPIN (follicle stimulating hormone) 522.1002
Injection.
200-266....................................... BUTEQUINE (phenylbutazone) Paste................ 520.1720c
200-432....................................... NEXHA (hyaluronate sodium) Injection............ 522.1145
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[[Page 74019]]
In addition, Veterinary Service, Inc. 4100 Bangs Ave., Modesto, CA
95356, has transferred ownership of, and all rights and interest in,
NADA 065-252 for STREP-SOL (streptomycin sulfate) Oral Solution to
Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria.
Also, Elanco Animal Health, Inc., A Division of Eli Lilly & Co.,
Lilly Corporate Center, Indianapolis, IN 46285, has transferred
ownership of, and all rights and interest in, NADA 141-272 for
RECONCILE (fluoxetine hydrochloride) Chewable Tablets to Nexcyon
Pharmaceuticals, Inc., 644 West Washington Ave., Madison, WI 53703.
At this time, the regulations are being amended to reflect these
changes of sponsorship. Following these changes of sponsorship, Akorn
Animal Health, Inc., Nexcyon Pharmaceuticals, Inc., and
V[eacute]toquinol USA, Inc. will now be the sponsors of an approved
application while Bioniche Animal Health USA, Inc. and Veterinary
Service, Inc. will no longer be the sponsors of an approved
application. Accordingly, 21 CFR 510.600(c) is being amended to reflect
these changes.
FDA is also amending the regulations at 21 CFR 558.76 to remove a
limitation on the concentrations of bacitracin methylene disalicyclate
Type A medicated articles that can be used to manufacture medicated
feed for quail. In addition, FDA is removing reserved 21 CFR 558.105
for which there is no entry. These actions are being taken to improve
the accuracy of the regulations.
Also, V[eacute]toquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie
(PQ), Canada, J5T 3S5, has requested that FDA withdraw approval of
ANADA 200-305 for Oxytetracycline Hydrochloride Soluble Powder because
the product is no longer manufactured or marketed. Note this ANADA was
identified as being affected by guidance for industry (GFI) #213, ``New
Animal Drugs and New Animal Drug Combination Products Administered in
or on Medicated Feed or Drinking Water of Food-Producing Animals:
Recommendations for Drug Sponsors for Voluntarily Aligning Product Use
Conditions with GFI #209,'' December 2013.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of ANADA 200-305, and all supplements and amendments
thereto, is withdrawn, effective December 26, 2014. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect this voluntary withdrawal of approval.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
Table 1--Original and Supplemental NADAs and ANADAs Approved During September and October 2014
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New animal drug 21 CFR NEPA
NADA/ ANADA Sponsor product name Action sections FOIA summary review
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141-244......... Zoetis Inc., DRAXXIN Supplemental 522.2630 yes............. CE1 2
333 Portage (tulathromycin approval for
St., ) Injectable treatment of
Kalamazoo, MI Solution. bovine
49007. respiratory
disease (BRD)
in suckling
calves, dairy
calves, and
veal calves.
141-430x\3\..... Phibro Animal STAFAC Original 558.355 yes............. CE1 4
Health Corp., (virginiamycin approval for
GlenPointe ) plus COBAN prevention of
Centre East, (monensin) coccidiosis
3d Floor, 300 combination and necrotic
Frank W. Burr drug Type C enteritis in
Blvd., suite medicated broiler
21, Teaneck, feeds. chickens.
NJ 07666.
200-522......... Putney, Inc., Carprofen Original 522.304 yes............. CE1 5
One Monument Sterile approval as a
Sq., suite Injectable generic copy
400, Portland, Solution. of NADA 141-
ME 04101. 199.
200-540......... Putney, Inc., Meloxicam Original 522.1367 yes............. CE1 5
One Monument (meloxicam) approval as a
Sq., suite Solution for generic copy
400, Portland, Injection. of NADA 141-
ME 04101. 219.
200-581......... Cross Vetpharm FLUNAZINE Original 520.970 yes............. CE1 5
Group Ltd., (flunixin approval as a
Broomhill Rd., meglumine) generic copy
Tallaght, Equine Paste. of NADA 137-
Dublin 24, 409.
Ireland.
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\1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an
environmental assessment or an environmental impact statement because it is of a type that does not have a
significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(d)(5).
\3\ This application is affected by GFI #213, ``New Animal Drugs and New Animal Drug Combination Products
Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209'', December 2013.
\4\ CE granted under 21 CFR 25.33(a)(2).
\5\ CE granted under 21 CFR 25.33(a)(1).
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 522
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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,
520, 522, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Bioniche Animal Health USA, Inc.'' and ``Veterinary
Service, Inc.'' and
[[Page 74020]]
alphabetically add entries for ``Akorn Animal Health, Inc.'', ``Nexcyon
Pharmaceuticals, Inc.'', and ``V[eacute]toquinol USA, Inc.''; and in
the table in paragraph (c)(2), remove the entries for ``033008'' and
``064847'' and numerically add entries for ``017030'', ``050929'', and
``053599'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug labeler
Firm name and address code
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* * * * *
Akorn Animal Health, Inc., 1925 West Field Ct., suite 053599
300, Lake Forest, IL 60045.............................
* * * * *
Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., 050929
Madison, WI 53719......................................
* * * * *
V[eacute]toquinol USA, Inc., 4250 N. Sylvania Ave., Fort 017030
Worth, TX 76137........................................
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
017030.............................. V[eacute]toquinol USA, Inc., 4250
N. Sylvania Ave., Fort Worth, TX
76137.
* * * * *
050929.............................. Nexcyon Pharmaceuticals, Inc., 644
West Washington Ave., Madison, WI
53719.
* * * * *
053599.............................. Akorn Animal Health, Inc., 1925
West Field Ct., suite 300, Lake
Forest, IL 60045.
* * * * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.970, revise paragraphs (b) and (c)(1) to read as
follows:
Sec. 520.970 Flunixin.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section.
(1) No. 000061 for use of products described in paragraph (a).
(2) No. 061623 for use of the product described in paragraph
(a)(2).
(c) * * *
(1) Amount. 0.5 mg per pound of body weight per day for up to 5
days.
* * * * *
Sec. 520.980 [Amended]
5. In paragraph (b) of Sec. 520.980, remove ``000986'' and in its
place add ``050929''.
Sec. 520.1660d [Amended]
0
6. In Sec. 520.1660d, remove paragraph (b)(8); and in paragraphs
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and
(d)(1)(iii)(C), remove ``059320,''.
Sec. 520.1720c [Amended]
0
7. In paragraph (b)(2) of Sec. 520.1720c, remove ``064847'' and in its
place add ``017030''.
Sec. 520.2158 [Amended]
0
8. In paragraph (b) of Sec. 520.2158, remove ``033008'' and in its
place add ``016592''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.246 [Amended]
0
10. In paragraph (b)(3) of Sec. 522.246, remove ``061690'' and in its
place add ``053599''.
0
11. In Sec. 522.304, revise paragraph (b) to read as follows:
Sec. 522.304 Carprofen.
* * * * *
(b) Sponsors. See Nos. 026637, 054771, and 055529 in Sec.
510.600(c) of this chapter.
* * * * *
Sec. 522.1002 [Amended]
0
12. In paragraph (c)(2) of Sec. 522.1002, remove ``064847'' and in its
place add ``017030''.
Sec. 522.1145 [Amended]
0
13. In paragraph (e)(2)(ii) of Sec. 522.1145, remove ``064847'' and in
its place add ``017030''.
0
14. In Sec. 522.1222, revise paragraph (b) to read as follows:
Sec. 522.1222 Ketamine.
* * * * *
(b) Sponsors. See Nos. 000859, 026637, 053599, 054628, 054771, and
063286 in Sec. 510.600(c) of this chapter.
* * * * *
0
15. In Sec. 522.1367, revise paragraph (b) to read as follows:
Sec. 522.1367 Meloxicam.
* * * * *
(b) Sponsors. See Nos. 000010, 016729, 026637, and 055529 in Sec.
510.600(c) of this chapter.
* * * * *
Sec. 522.2474 [Amended]
0
16. In paragraph (b) of Sec. 522.2474, remove ``061690'' and in its
place add ``053599''.
0
17. In Sec. 522.2630, revise paragraph (d)(1) to read as follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(d) * * *
(1) Cattle--(i) Amount. 2.5 mg per kilogram (/kg) body weight as a
single subcutaneous injection in the neck.
(ii) Indications for use--(A) Beef and non-lactating dairy cattle;
suckling calves, dairy calves, and veal calves: For the treatment of
bovine respiratory disease (BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma
bovis;
(B) Beef and non-lactating dairy cattle: For the control of
respiratory disease in cattle at high risk of developing BRD associated
with M. haemolytica, P. multocida, H. somni, and M. bovis. For the
treatment of infectious bovine keratoconjunctivitis associated with
Moraxella bovis. For the treatment of bovine foot rot (interdigital
necrobacillosis) associated with Fusobacterium necrophorum and
Porphyromonas levii.
(iii) Limitations. Cattle intended for human consumption must not
be slaughtered within 18 days from the last treatment. Do not use in
female dairy cattle 20 months of age or older. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
* * * * *
Sec. 522.2662 [Amended]
0
18. In paragraph (b)(4) of Sec. 522.2662, remove ``061690'' and in its
place add ``053599''.
0
19. Revise Sec. 522.2670 to read as follows:
Sec. 522.2670 Yohimbine.
(a) Specifications. Each milliliter (mL) of solution contains 2 or
5 milligrams (mg) of yohimbine (as hydrochloride).
[[Page 74021]]
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section.
(1) No. 053599 for use of in 2 mg/mL solution as in paragraph
(c)(1) of this section.
(2) No. 053923 for use of in 5 mg/mL solution as in paragraph
(c)(2) of this section.
(c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.05 mg per
pound (0.11 mg per kilogram) of body weight by intravenous injection.
(ii) Indications for use. To reverse the effects of xylazine in
dogs.
(iii) Limitations. Not for use in food-producing animals. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Deer and elk--(i) Amount. Administer 0.2 to 0.3 mg per kilogram
of body weight by intravenous injection.
(ii) Indications for use. A s an antagonist to xylazine sedation in
free ranging or confined members of the family Cervidae (deer and elk).
(iii) Limitations. Do not use in domestic food-producing animals.
Do not use for 30 days before or during hunting season. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
20. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.76 [Amended]
0
21. In Sec. 558.76, in paragraph (d)(1)(x), in the entry for
``Quail'', in the ``Limitations'' column, remove the first sentence.
Sec. 558.105 [Removed]
0
22. Remove reserved Sec. 558.105.
0
23. In Sec. 558.355, add paragraph (f)(1)(xxxi) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(1) * * *
(xxxi) Amount per ton. Monensin, 90 to 110 grams; plus
virginiamycin, 20 grams.
(a) Indications for use. Broiler chickens: As an aid in the
prevention of coccidiosis caused by E. necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and E. maxima; and for prevention
of necrotic enteritis caused by Clostridium perfringens susceptible to
virginiamycin.
(b) Limitations. Feed continuously as sole ration. Do not feed to
laying chickens. See paragraph (d) of this section. As monensin
provided by No. 000986; virginiamycin as provided by No. 066104 in
Sec. 510.600(c) of this chapter.
* * * * *
Dated: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-29249 Filed 12-12-14; 8:45 am]
BILLING CODE 4164-01-P