New Animal Drugs; Approval of New Animal Drug Applications
Federal Register, Volume 80 Issue 172 (Friday, September 4, 2015)
Federal Register Volume 80, Number 172 (Friday, September 4, 2015)
Rules and Regulations
Pages 53458-53463
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-21905
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 524, and 558
Docket No. FDA-2015-N-0002
New Animal Drugs; Approval of New Animal Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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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 May and June 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 a nonsubstantive change. This technical amendment is being made to improve the accuracy of the regulations.
DATES: This rule is effective September 4, 2015.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during May and June 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 May and June 2015
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New animal drug 21 CFR
NADA/ANADA Sponsor product name Action sections FOIA summary NEPA review
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141-417........................... Bayer HealthCare LLC, CORAXIS (moxidectin) Original approval 524.1450 yes............ CE.\1\ \2\
Animal Health Topical Solution for for the prevention
Division, P.O. Box Dogs. of heartworm
390, Shawnee disease, and for
Mission, KS 66201. the treatment and
control of
intestinal
hookworm, roundworm
and whipworm
infections in dogs.
141-188........................... Merial Inc., 3239 MARQUIS (ponazuril) Supplemental 520.1855 yes............ CE.\1\ \2\
Satellite Blvd., Oral Paste. approval of a
Bldg. 500, Duluth, revised dosage that
GA 30096-4640. includes a loading
dose on the first
day of treatment.
141-262........................... Zoetis Inc., 333 CERENIA (maropitant Supplemental 520.1315 yes............ CE.\1\ \2\
Portage St., citrate) Tablets. approval extending
Kalamazoo, MI 49007. duration of daily
administration
until resolution of
acute vomiting.
Page 53459
141-291........................... Dechra, Ltd., VETORYL (trilostane) Supplemental 520.2598 no............. CE.\1\ \2\
Snaygill Industrial Capsules. approval of a 5-
Estate, Keighley milligram capsule
Rd., Skipton, North size.
Yorkshire, BD23 2RW,
United Kingdom.
141-278........................... Intervet, Inc., 2 ZILMAX (zilpaterol Supplemental 558.665 yes............ CE.\1\ \3\
Giralda Farms, hydrochloride) plus approval to provide
Madison, NJ 07940. RUMENSIN (monensin). for component
Type A medicated feeding of
articles. combination drug
Type C medicated
feeds to cattle fed
in confinement for
slaughter.
141-282........................... Intervet, Inc., 2 ZILMAX (zilpaterol Supplemental 558.665 yes............ CE.\1\ \3\
Giralda Farms, hydrochloride) plus approval to provide
Madison, NJ 07940. RUMENSIN (monensin) for component
plus MGA feeding of
(melengestrol combination drug
acetate). Type C medicated
Type A medicated feeds to heifers
articles. fed in confinement
for slaughter.
141-284........................... Intervet, Inc., 2 ZILMAX (zilpaterol Supplemental 558.665 yes............ CE.\1\ \3\
Giralda Farms, hydrochloride) plus approval to provide
Madison, NJ 07940. MGA (melengestrol for component
acetate). feeding of
Type A medicated combination drug
articles. Type C medicated
feeds to heifers
fed in confinement
for slaughter.
200-497........................... Norbrook LOXICOM (meloxicam) Original approval as 520.1367 yes............ CE.\1\ \3\
Laboratories, Ltd., 1.5 mg/mL Oral a generic copy of
Station Works, Newry Suspension. NADA 141-213.
BT35 6JP, Northern
Ireland.
200-580........................... Huvepharma AD, 5th TYLOVET (tylosin Original approval as \4\ 558.550 yes............ CE.\1\ \3\
Floor, 3A Nikolay phosphate) plus a generic copy of
Haytov Str., 1113 SACOX (salinomycin NADA 141-198.
Sophia, Bulgaria. sodium)
Type C medicated
feeds.
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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)(1).
\3\ CE granted under 21 CFR 25.33(a)(1).
\4\ The regulation does not require amendment.
Also, the animal drug regulations are being amended to reflect approved labeling for hand feeding bambermycins medicated cattle feed. This technical amendment is 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
21 CFR Parts 520 and 524
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 520, 524, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
-
The authority citation for 21 CFR part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
-
In Sec. 520.1315, revise paragraph (c)(1) to read as follows:
Sec. 520.1315 Maropitant.
* * * * *
(c) * * *
(1) Indications for use and amount. (i) For prevention of acute vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 consecutive days.
(ii) For prevention of acute vomiting in dogs 7 months of age and older, administer a minimum dose of 2.0 mg/kg body weight once daily until resolution of acute vomiting.
(iii) For prevention of vomiting due to motion sickness in dogs 4 months of age and older, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days.
* * * * *
Sec. 520.1367 Amended
0
-
In Sec. 520.1367, in paragraph (b)(2), remove ``No. 013744'' and in its place add ``Nos. 013744 and 055529''.
0
-
In Sec. 520.1855, revise paragraph (c)(1) to read as follows:
Sec. 520.1855 Ponazuril.
* * * * *
(c) * * *
Page 53460
(1) Amount. Administer orally 15 mg per kilogram (kg) (6.81 mg per pound (lb)) body weight as the first dose, followed by 5 mg/kg (2.27 mg/lb) body weight once daily for a period of 27 additional days.
* * * * *
Sec. 520.2598 Amended
0
-
In Sec. 520.2598, in paragraph (a), remove ``10, 30, or 60 milligrams'' and in its place add ``5, 10, 30, 60, or 120 milligrams''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
-
The authority citation for 21 CFR part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
-
In Sec. 524.1450, and revise paragraphs (a), (b), and (d), and remove paragraph (e).
The revisions read as follows:
Sec. 524.1450 Moxidectin.
(a) Specifications. Each milliliter of solution contains:
(1) 5 milligrams (mg) moxidectin (0.5 percent solution).
(2) 25 mg moxidectin (2.5 percent solution).
(b) Sponsors. See sponsor numbers in Sec. 510.600 of this chapter:
(1) No. 000010 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section;
(2) No. 000859 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
* * * * *
(d) Conditions of use--(1) Cattle--(i) Amount. Administer topically 0.5 mg per kilogram (kg) of body weight.
(ii) Indications for use. Beef and dairy cattle: For treatment and control of internal and external parasites: gastrointestinal roundworms (Ostertagia ostertagi (adult and L4, including inhibited larvae), Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. surnabada (adult and L4), Bunostomum phlebotomum (adult), Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult and L4)); lungworms (Dictyocaulus viviparus (adult and L4)); cattle grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola (Damalinia) bovis); and horn flies (Haematobia irritans). To control infections and to protect from reinfection with H. placei for 14 days after treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. viviparus for 42 days after treatment.
(iii) Limitations. A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal. See Sec. 500.25 of this chapter.
(2) Dogs--(i) Amount. Administer topically a minimum of 1.1 mg per pound (lb) (2.5 mg/kg) of body weight, once monthly using the appropriate preloaded applicator tube.
(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis, as well as the treatment and control of intestinal hookworm (Ancylostoma caninum (adult, immature adult, and L4 larvae) and Uncinaria stenocephala (adult, immature adult, and L4 larvae)), roundworm (Toxocara canis (adult and L4 larvae) and Toxascaris leonina (adult)), and whipworm (Trichuris vulpis (adult)) infections in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 lbs.
(iii) Limitations. 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
-
The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.95 Amended
0
-
In Sec. 558.95, in the table in paragraph (d)(4)(ii), in the ``Bambermycins in grams/ton'' column, remove ``2 to 40'' and in its place add ``2 to 80''; and in the ``Limitations'' column, remove the first sentence and in its place add ``Feed continuously on a hand-fed basis at a rate of 10 to 40 milligrams per head per day in 1 to 10 pounds of supplemental Type C medicated feed.''.
0
-
In Sec. 558.665, revise paragraphs (d)(2) and (e) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(d) * * *
(2) Labeling of Type A medicated articles and Type B medicated feeds used to manufacture complete Type C medicated feeds shall bear the caution statement in paragraph (d)(3) of this section.
* * * * *
(e) Conditions of use in cattle. It is administered in feed as follows:
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Zilpaterol
hydrochloride in grams/ Combination in grams/ Indications for use Limitations Sponsor
ton ton
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(1) 6.8............... ..................... Cattle fed in confinement Feed continuously as the 000061
for slaughter: For sole ration during the
increased rate of weight last 20 to 40 days on
gain, improved feed feed to provide 60 to 90
efficiency, and mg zilpaterol
increased carcass hydrochloride per head
leanness in cattle fed per day. Withdrawal
in confinement for period: 3 days. See
slaughter during the paragraph (d) of this
last 20 to 40 days on section.
feed.
(2) 6.8............... Monensin 10 to 40.... Cattle fed in confinement Feed continuously as the 000061
for slaughter: For sole ration during the 000986
increased rate of weight last 20 to 40 days on
gain, improved feed feed to provide 60 to 90
efficiency, and mg zilpaterol
increased carcass hydrochloride per head
leanness in cattle fed per day and 0.14 to 0.42
in confinement for mg monensin per pound of
slaughter during the body weight per day
last 20 to 40 days on depending on the
feed; for prevention and severity of the
control of coccidiosis coccidiosis challenge,
due to Eimeria bovis and up to 480 mg/head/day
E. zuernii. monensin. Withdrawal
period: 3 days. See
paragraph (d) of this
section. See paragraph
Sec. 558.355(d) of
this chapter Monensin as
provided by No. 000986
in Sec. 510.600(c) of
this chapter.
Page 53461
(3) 6.8............... Melengestrol acetate Heifers fed in Feed continuously as the 000061
to provide 0.25 to confinement for sole ration during the 000986
0.5 mg/head/day. slaughter: For increased last 20 to 40 days on
rate of weight gain, feed to provide 60 to 90
improved feed mg zilpaterol
efficiency, and hydrochloride per head
increased carcass per day. Withdrawal
leanness in cattle fed period: 3 days. See
in confinement for paragraph (d) of this
slaughter during the section.
last 20 to 40 days on Melengestrol acetate as
feed; and for provided by Nos. 000986
suppression of estrus or 054771 in Sec.
(heat). 510.600(c) of this
chapter.
(4) 6.8............... Monensin 10 to 40 Heifers fed in Feed continuously as the 000061
plus melengestrol confinement for sole ration during the 000986
acetate to provide slaughter: For increased last 20 to 40 days on
0.25 to 0.5 mg/head/ rate of weight gain, feed to provide 60 to 90
day. improved feed mg zilpaterol
efficiency, and hydrochloride per head
increased carcass per day and 0.14 to 0.42
leanness in cattle fed mg monensin per pound of
in confinement for body weight per day
slaughter during the depending on the
last 20 to 40 days on severity of the
feed; for prevention and coccidiosis challenge,
control of coccidiosis up to 480 mg/head/day
due to Eimeria bovis and monensin. Withdrawal
E. zuernii; and for period: 3 days. See
suppression of estrus paragraph (d) of this
(heat). section. See paragraphs
Sec. Sec. 558.342(d)
and 558.355(d) of this
chapter.
Monensin as provided by
No. 000986; melengestrol
acetate as provided by
Nos. 000986 or 054771 in
Sec. 510.600(c) of
this chapter.
(5) 6.8............... Monensin 10 to 40, For increased rate of Feed continuously as the 000061
plus tylosin 8 to 10. weight gain, improved sole ration during the 016592
feed efficiency, and last 20 to 40 days on
increased carcass feed to provide 60 to 90
leanness in cattle fed mg zilpaterol
in confinement for hydrochloride per head
slaughter during the per day and 0.14 to 0.42
last 20 to 40 days on mg monensin per pound of
feed; for prevention and body weight per day
control of coccidiosis depending on the
due to Eimeria bovis and severity of the
E. zuernii; and for coccidiosis challenge,
reduction of incidence up to 480 mg/head/day
of liver abscesses monensin. Withdrawal
caused by Fusobacterium period: 3 days. See
necrophorum and paragraph (d) of this
Arcanobacterium section. See paragraphs
(Actinomyces) pyogenes. Sec. Sec. 558.355(d)
and 558.625(c) of this
chapter.
Monensin as provided by
No. 000986; tylosin as
provided by Nos. 000986
or 016592 in Sec.
510.600(c) of this
chapter.
(6) 6.8............... Monensin 10 to 40, Heifers fed in Feed continuously as the 000061
plus tylosin 8 to confinement for sole ration during the 000986
10, plus slaughter: For increased last 20 to 40 days on 016592
melengestrol acetate rate of weight gain, feed to provide 60 to 90
to provide 0.25 to improved feed mg zilpaterol
0.5 mg/head/day. efficiency, and hydrochloride per head
increased carcass per day and 0.14 to 0.42
leanness in cattle fed mg monensin per pound of
in confinement for body weight per day
slaughter during the depending on the
last 20 to 40 days on severity of the
feed; for prevention and coccidiosis challenge,
control of coccidiosis up to 480 mg/head/day
due to Eimeria bovis and monensin. Withdrawal
E. zuernii; for period: 3 days. See
reduction of incidence paragraph (d) of this
of liver abscesses section. See paragraphs
caused by Fusobacterium Sec. Sec. 558.342(d),
necrophorum and 558.355(d), and
Arcanobacterium 558.625(c) of this
(Actinomyces) pyogenes; chapter.
and for suppression of Monensin as provided by
estrus (heat). No. 000986; tylosin as
provided by Nos. 000986
or 016592; and
melengestrol acetate as
provided by Nos. 000986
or 054771 in Sec.
510.600(c) of this
chapter.
(7) 6.8 to 24......... ..................... Cattle fed in confinement Feed continuously during 000061
for slaughter: For the last 20 to 40 days
increased rate of weight on feed to provide 60 mg
gain, improved feed zilpaterol hydrochloride
efficiency, and per head per day.
increased carcass Withdrawal period: 3
leanness in cattle fed days. See paragraph (d)
in confinement for of this section.
slaughter during the
last 20 to 40 days on
feed.
Page 53462
(8) 6.8 to 24......... Monensin 10 to 40.... Cattle fed in confinement Feed continuously during 000061
for slaughter: For the last 20 to 40 days
increased rate of weight on feed to provide 60 mg
gain, improved feed zilpaterol hydrochloride
efficiency, and per head per day and
increased carcass 0.14 to 0.42 mg monensin
leanness in cattle fed per pound of body weight
in confinement for per day depending on the
slaughter during the severity of the
last 20 to 40 days on coccidiosis challenge,
feed; and for prevention up to 480 mg/head/day
and control of monensin. Withdrawal
coccidiosis due to period: 3 days. See
Eimeria bovis and E. paragraph (d) of this
zuernii. section. See paragraph
Sec. 558.355(d) of
this chapter.
Monensin as provided by
No. 000986 in Sec.
510.600(c) of this
chapter.
(9) 6.8 to 24......... Melengestrol acetate Heifers fed in Feed continuously during 000061
to provide 0.25 to confinement for the last 20 to 40 days
0.5 mg/head/day. slaughter: For increased on feed to provide 60 mg
rate of weight gain, zilpaterol hydrochloride
improved feed per head per day.
efficiency, and Withdrawal period: 3
increased carcass days. See paragraph (d)
leanness in cattle fed of this section. See
in confinement for paragraph Sec.
slaughter during the 558.342(d) of this part.
last 20 to 40 days on Melengestrol acetate as
feed; and for provided by No. 054771
suppression of estrus in Sec. 510.600(c) of
(heat). this chapter.
(10) 6.8 to 24........ Monensin 10 to 40, Heifers fed in Feed continuously during 000061
plus melengestrol confinement for the last 20 to 40 days
acetate to provide slaughter: For increased on feed to provide 60 mg
0.25 to 0.5 mg/head/ rate of weight gain, zilpaterol hydrochloride
day. improved feed per head per day and
efficiency, and 0.14 to 0.42 mg monensin
increased carcass per pound of body weight
leanness in cattle fed per day depending on the
in confinement for severity of the
slaughter during the coccidiosis challenge,
last 20 to 40 days on up to 480 mg/head/day
feed; for prevention and monensin. Withdrawal
control of coccidiosis period: 3 days. See
due to Eimeria bovis and paragraph (d) of this
E. zuernii; and for section. See paragraphs
suppression of estrus Sec. Sec. 558.342(d)
(heat). and 558.355(d) of this
chapter.
Monensin as provided by
No. 000986; melengestrol
acetate as provided by
No. 054771 in Sec.
510.600(c) of this
chapter.
(11) 6.8 to 24........ Monensin 10 to 40, Cattle fed in confinement Feed continuously during 000061
plus tylosin 8 to 10. for slaughter: For the last 20 to 40 days
increased rate of weight on feed to provide 60 mg
gain, improved feed zilpaterol hydrochloride
efficiency, and per head per day and
increased carcass 0.14 to 0.42 mg monensin
leanness in cattle fed per pound of body weight
in confinement for per day depending on the
slaughter during the severity of the
last 20 to 40 days on coccidiosis challenge,
feed; for prevention and up to 480 mg/head/day
control of coccidiosis monensin. Withdrawal
due to Eimeria bovis and period: 3 days. See
E. zuernii; and for paragraph (d) of this
reduction of incidence section. See paragraphs
of liver abscesses Sec. Sec. 558.355(d)
caused by Fusobacterium and 558.625(c) of this
necrophorum and chapter.
Arcanobacterium Monensin and tylosin as
(Actinomyces) pyogenes. provided by No. 000986
in Sec. 510.600(c) of
this chapter.
(12) 6.8 to 24........ Monensin 10 to 40, Heifers fed in Feed continuously during 000061
plus tylosin 8 to confinement for the last 20 to 40 days
10, plus slaughter: For increased on feed to provide 60 mg
melengestrol acetate rate of weight gain, zilpaterol hydrochloride
to provide 0.25 to improved feed per head per day and
0.5 mg/head/day. efficiency, and 0.14 to 0.42 mg monensin
increased carcass per pound of body weight
leanness in cattle fed per day depending on the
in confinement for severity of the
slaughter during the coccidiosis challenge,
last 20 to 40 days on up to 480 mg/head/day
feed; for prevention and monensin. Withdrawal
control of coccidiosis period: 3 days. See
due to Eimeria bovis and paragraph (d) of this
E. zuernii; for section. See paragraphs
reduction of incidence Sec. Sec. 558.342(d),
of liver abscesses 558.355(d), and
caused by Fusobacterium 558.625(c) of this
necrophorum and chapter.
Arcanobacterium Monensin and tylosin as
(Actinomyces) pyogenes; provided by No. 000986;
and for suppression of melengestrol acetate as
estrus (heat). provided by No. 054771
in Sec. 510.600(c) of
this chapter.
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Dated: August 31, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. 2015-21905 Filed 9-3-15; 8:45 am
BILLING CODE 4164-01-P
