New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address
Federal Register, Volume 80 Issue 67 (Wednesday, April 8, 2015)
Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)
Rules and Regulations
Pages 18773-18777
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2015-08025
Page 18773
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, and 558
Docket No. FDA-2015-N-0002
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2015. 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 several non-substantive changes. These technical amendments are being made to improve the accuracy of the regulations.
DATES: This rule is effective April 8, 2015, except for the amendment to 21 CFR 522.1004, which is effective April 20, 2015.
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, george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January and February 2015, 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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action sections FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-435................ Piedmont Animal ADVANTUS Original approval for 520.1156 yes..................... CE 1 2
Health, 204 Muirs (imidacloprid) the treatment of
Chapel Rd., Suite Chewable Tablets. flea infestations on
200, Greensboro, NC dogs and puppies.
27410.
141-418................ Luitpold BETAVET (betamethasone Original approval for 522.167 yes..................... CE 1 2
Pharmaceuticals, sodium phosphate and the control of pain
Inc., Animal Health betamethasone and inflammation
Division, Shirley, NY acetate) Injectable associated with
11967. Suspension. osteoarthritis in
horses.
200-527................ Putney, Inc., One Enrofloxacin Original approval as 522.812 yes..................... CE 1 3
Monument Sq., suite Antibacterial a generic copy of
400, Portland, ME Injectable Solution. NADA 140-913.
04101.
200-576................ Akorn Animal Health, Gentamicin Sulfate Original approval as 524.1044a yes..................... CE 1 3
Inc., 1925 West Field Ophthalmic Solution. a generic copy of
Ct., suite 300, Lake NADA 099-008.
Forest, IL 60045.
Page 18774
141-280 \4\............ Intervet, Inc., 556 ZILMAX (zilpaterol Supplemental approval 558.665 yes..................... CE 1 5
Morris Ave., Summit, hydrochloride) plus to provide for
NJ 07901. RUMENSIN (monensin) component feeding of
plus TYLAN (tylosin combination drug
phosphate) plus MGA Type C medicated
(melengestrol feeds to heifers fed
acetate) Type A in confinement for
medicated articles. slaughter.
141-406................ Merial, Inc., 3239 NEXGARD (afoxolaner) Supplemental approval 520.43 yes..................... CE 1 2
Satellite Blvd., Chewable Tablets. for the treatment
Bldg. 500, Duluth, GA and control of an
30096-4640. additional tick
species in dogs and
puppies.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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)(1).
\3\ CE granted under 21 CFR 25.33(a)(1).
\4\ This application is 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
\5\ CE granted under 21 CFR 25.33(a)(2).
In addition during January and February 2015, ownership of, and all rights and interest in, the following approved applications have been transferred as follows:
----------------------------------------------------------------------------------------------------------------
New animal drug
NADA/ANADA Previous sponsor product name New sponsor 21 CFR Section
----------------------------------------------------------------------------------------------------------------
141-098................. Abbott Laboratories, PROPOFLO (propofol) Zoetis Inc., 333 522.2005
North Chicago, IL Injectable Suspension. Portage St.,
60064. Kalamazoo, MI 49007.
141-103................. Abbott Laboratories, SEVOFLO (sevoflurane) Zoetis Inc., 333 529.2150
North Chicago, IL Inhalation Anesthetic. Portage St.,
60064. Kalamazoo, MI 49007.
141-346................. Abbott Laboratories, OROCAM (meloxicam) Zoetis Inc., 333 529.1350
North Chicago, IL Oral Spray. Portage St.,
60064. Kalamazoo, MI 49007.
141-434................. Abbott Laboratories, SIMBADOL Zoetis Inc., 333 522.230
North Chicago, IL (buprenorphine) Portage St.,
60064. Injectable Solution. Kalamazoo, MI 49007.
200-070................. Abbott Laboratories, ISOFLO (isoflurane) Zoetis Inc., 333 529.1186
North Chicago, IL Inhalation Anesthetic. Portage St.,
60064. Kalamazoo, MI 49007.
048-480................. ADM Alliance CHLORATET 90 and 100 Pharmgate LLC, 161 558.128
Nutrition., Inc., (chlortetracycline) North Franklin
1000 North 30th St., Type A medicated Turnpike, suite 2C,
Quincy, IL 62305-3115. articles. Ramsey, NJ 07446.
065-256................. ADM Alliance CHLORTET-SOLUBLE-O Pharmgate LLC, 161 520.441
Nutrition., Inc., (chlortetracycline) North Franklin
1000 North 30th St., Powder. Turnpike, suite 2C,
Quincy, IL 62305-3115. Ramsey, NJ 07446.
200-197................. Contemporary Products, Streptomycin Oral Huvepharma AD, 5th 520.2158
Inc., 3788 Elm Solution. Floor, 3A Nikolay
Springs Rd., Haitov Str., 1113
Springdale, AR 72764- Sofia, Bulgaria.
6067.
141-084................. Novartis Animal Health SENTINEL (milbemycin Virbac AH, Inc., 3200 522.1143
US, Inc., 3200 oxime and lufenuron) Meacham Blvd., Ft.
Northline Ave., suite FLAVOR TABS. Worth, TX 76137.
300, Greensboro, NC
27408.
141-204................. Novartis Animal Health SENTINEL (milbemycin Virbac AH, Inc., 3200 520.1510
US, Inc., 3200 oxime and lufenuron) Meacham Blvd., Ft.
Northline Ave., suite FLAVOR TABS and Worth, TX 76137.
300, Greensboro, NC CAPSTAR (nitenpyram)
27408. Tablets Flea
Management Program.
141-333................. Novartis Animal Health SENTINEL SPECTRUM Virbac AH, Inc., 3200 520.1447
US, Inc., 3200 (milbemycin oxime/ Meacham Blvd., Ft.
Northline Ave., suite lufenuron/ Worth, TX 76137.
300, Greensboro, NC praziquantel) Tablets.
27408.
141-067................. OPK Biotech, LLC, 11 OXYGLOBIN (hemoglobin Hemoglobin Oxygen 522.1125
and 39 Hurley St., glutamer-200 Therapeutics, LLC,
Cambridge, MA. (bovine)). 674 Souder Rd.,
Souderton, PA 18964.
----------------------------------------------------------------------------------------------------------------
Page 18775
At this time, the regulations are being amended to reflect these changes of sponsorship.
In addition, Paladin Labs (USA), Inc., 160 Greentree Dr., Suite 101, Dover, DE 19904 has requested that FDA withdraw approval of NADA 141-075 for ANTIZOL-VET (fomepizole) Injection. Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 141-075, and all supplements and amendments thereto, is withdrawn, effective April 20, 2015. As provided in the regulatory text of this document, the animal drug regulations are being amended to reflect this voluntary withdrawal of approval.
Following these changes of sponsorship and withdrawal of approval, Hemoglobin Oxygen Therapeutics, LLC is now the sponsor of an approved application while OPK Biotech, LLC and Paladin Labs (USA), Inc., are no longer the sponsor of an approved application. Also, Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, has informed FDA that it has changed its name to Merial, Inc., and Intervet, Inc., 556 Morris Ave., Summit, NJ 07901, has informed FDA that it has changed its address to 2 Giralda Farms, Madison, NJ 07940. Accordingly, Sec. 510.600 (21 CFR 510.600) is being amended to reflect these changes.
In addition, FDA is amending the tables in Sec. 510.600(c) to remove listings for International Nutrition, Inc.; NutriBasics Co.; Seeco Inc.; Southern Micro-Blenders, Inc.; and Wellmark International because these firms are no longer the sponsor of an approved application. These technical amendments are being made to improve the accuracy of the regulations.
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.
List of Subjects
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
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, 524, 529, 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. Amend Sec. 510.600 as follows:
0
-
In the table in paragraph (c)(1), remove the entries for ``Contemporary Products, Inc.'', ``International Nutrition, Inc.'', ``NutriBasics Co.'', ``OPK Biotech, LLC'', ``Paladin Labs (USA), Inc.'', ``Seeco Inc.'', ``Southern Micro-Blenders, Inc.'', and ``Wellmark International'';
0
-
In the table in paragraph (c)(1), revise the entries for ``Intervet, Inc.'' and ``Merial Ltd.''; and add an entry, in alphabetical order, for ``Hemoglobin Oxygen Therapeutics, LLC'';
0
-
In the table in paragraph (c)(2), remove the entries for ``011536'', ``043733'', ``046129'', and ``055462''; and
0
-
In the table in paragraph (c)(2), revise the entries for ``000061'', ``050604'', and ``063075''.
The additions and revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., 063075
Souderton, PA 18964....................................
* * * * *
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940...... 000061
* * * * *
Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, 050604
GA 30096-4640..........................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
000061.............................. Intervet, Inc., 2 Giralda Farms,
Madison, NJ 07940.
* * * * *
050604.............................. Merial, Inc., 3239 Satellite
Blvd., Bldg. 500, Duluth, GA
30096-4640.
* * * * *
063075.............................. Hemoglobin Oxygen Therapeutics,
LLC, 674 Souder Rd., Souderton,
PA 18964.
* * * * *
------------------------------------------------------------------------
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. 520.43, revise paragraph (c)(2) to read as follows:
Sec. 520.43 Afoxolaner.
* * * * *
(c) * * *
(2) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis); for the treatment and control of black-legged tick (Ixodes scapularis), American dog tick (Dermacentor variabilis), lone star tick (Amblyomma americanum), and brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 lb of body weight or greater, for 1 month.
* * * * *
Sec. 520.441 Amended
0
5. In Sec. 520.441, in paragraph (b)(4), remove ``012286'' and in its place add ``069254''.
0
6. Add Sec. 520.1156 to read as follows:
Sec. 520.1156 Imidacloprid.
(a) Specifications. Each chewable tablet contains 7.5 or 37.5 milligrams (mg) imidacloprid.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer daily one 7.5-mg chewable tablet to dogs weighing 4 to 22 pounds (lb) or one 37.5-mg chewable table to dogs weighing 23 to 110 lb.
(2) Indications for use. Kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 lb or greater.
(3) Limitations. Do not give to puppies younger than 10 weeks of age or to dogs weighing less than 4 lb. Do not give more than one tablet a day.
Page 18776
Sec. 520.1443 Amended
0
7. In Sec. 520.1443, in paragraph (b), remove ``058198'' and in its place add ``051311''.
Sec. 520.1447 Amended
0
8. In Sec. 520.1447, in paragraph (b), remove ``058198'' and in its place add ``051311''.
0
9. In Sec. 520.1510, in paragraph (d)(1)(ii)(B), remove ``Sec. 520.1446(d)(1) of this chapter'' and in its place add ``Sec. 520.1443(d)(1)''; and revise the section heading and paragraph (b) to read as follows:
Sec. 520.1510 Nitenpyram.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter:
(1) No. 058198 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of this section.
(2) No. 051311 for use as in paragraphs (d)(1)(i)(B) and (d)(1)(ii)(B) of this section.
* * * * *
Sec. 520.2158 Amended
0
10. In Sec. 520.2158, in paragraph (b), remove ``Nos. 016592 and 055462'' and in its place add ``No. 016592''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for 21 CFR part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
12. Add Sec. 522.167 to read as follows:
Sec. 522.167 Betamethasone sodium phosphate and betamethasone acetate.
(a) Specifications. Each milliliter (mL) of suspension contains 6 milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate and 2.85 mg betamethasone acetate).
(b) Sponsor. See No. 010797 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 1.5 mL (9 mg total betamethasone) per joint by intra-articular injection. May be administered concurrently in up to two joints per horse.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in horses.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Sec. 522.230 Amended
0
13. In Sec. 522.230, in paragraph (b), remove ``000044'' and in its place add ``054771''.
0
14. In Sec. 522.812, add paragraph (b)(3) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(3) No. 026637 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section.
* * * * *
Sec. 522.1004 Removed
0
15. Remove Sec. 522.1004.
0
16. In Sec. 522.2005, remove paragraph (b)(3); and revise paragraph (b)(2) to read as follows:
Sec. 522.2005 Propofol.
* * * * *
(b) * * *
(2) No. 054771 for use as in paragraph (c) of this section.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for 21 CFR part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
18. Revise Sec. 524.1044a to read as follows:
Sec. 524.1044a Gentamicin ophthalmic solution.
(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.
(b) Sponsors. See Nos. 000061 and 059399 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Administer 1 or 2 drops into the conjunctival sac 2 to 4 times a day.
(2) Indications for use. For the topical treatment of infections of the conjunctiva caused by susceptible bacteria.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
19. The authority citation for 21 CFR part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1186 Amended
0
20. In Sec. 529.1186, in paragraph (b), remove ``000044'' and add ``054771,'' after ``012164,''.
Sec. 529.1350 Amended
0
21. In Sec. 529.1350, in paragraph (b), remove ``000074'' and in its place add ``054771''.
Sec. 529.2150 Amended
0
22. In Sec. 529.2150, in paragraph (b), remove ``000044'' and add ``054771,'' after ``012164,''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
23. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.128 Amended
0
24. Amend Sec. 558.128 as follows:
0
-
In paragraph (b)(2), remove ``No. 012286'' and in its place add ``No. 069254'';
0
-
In paragraph (e)(3)(iv), in the ``Limitations'' column, remove ``012286'' and in its place add ``069254''; and
0
-
In the tables in paragraphs (e)(1), (e)(2), (e)(3), and (e)(4), in the ``Sponsor'' column, remove ``012286,'' wherever it occurs.
0
25. In Sec. 558.665, add paragraph (e)(9) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
Page 18777
----------------------------------------------------------------------------------------------------------------
Combination in
Zilpaterol in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(9) 6.8 to 24.................... Monensin 10 to 40, Heifers fed in Feed continuously 000061
plus tylosin 8 to confinement for to heifers during
10, plus slaughter: For the last 20 to 40
melengestrol increased rate of days on feed to
acetate to provide weight gain, provide 60 mg
0.25 to 0.5 mg/ improved feed zilpaterol
head/day. efficiency, and hydrochloride per
increased carcass head per day. See
leanness in cattle Sec. Sec.
fed in confinement 558.342(d),
for slaughter 558.355(d), and
during the last 20 558.625(c).
to 40 days on Monensin and
feed; for tylosin as
prevention and provided by No.
control of 000986;
coccidiosis due to melengestrol
Eimeria bovis and acetate as
E. zuernii; and provided by No.
for reduction of 054771 in Sec.
incidence of liver 510.600(c) of this
abscesses caused chapter.
by Fusobacterium Withdrawal period:
necrophorum and 3 days.
Arcanobacterium
(Actinomyces)
pyogenes; and for
suppression of
estrus (heat).
----------------------------------------------------------------------------------------------------------------
Dated: April 3, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. 2015-08025 Filed 4-7-15; 8:45 am
BILLING CODE 4164-01-P
