New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application, 11509 [2017-03678]
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Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
§ 558.68
16. In § 558.68, revise paragraph
(e)(1)(ii) to read as follows:
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Avilamycin.
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(e) * * *
(1) * * *
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Avilamycin in
grams/ton
Combination in
grams/ton
Indications for use
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(ii) 13.6 to 40.9 ........
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Monensin 90 to 110;
as provided by
No. 058198 in
§ 510.600(c) of
this chapter.
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Broiler chickens: For the prevention of
mortality caused by necrotic enteritis
associated with Clostridium perfringens
in broiler chickens; and as an aid in the
prevention of coccidiosis caused by
Eimeria necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and
E. maxima.
Limitations
[Docket No. FDA–2016–N–0002]
New Animal Drugs; Withdrawal of
Approval of a New Animal Drug
Application
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
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Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03677 Filed 2–23–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
AGENCY:
Food and Drug Administration,
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of an abbreviated new animal
drug application (ANADA) at the
sponsor’s request because the product is
no longer manufactured or marketed.
DATES: Withdrawal of approval is
effective March 6, 2017.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Putney,
Inc., One Monument Square, Suite 400,
Portland, ME 04101 has requested that
FDA withdraw approval of ANADA
200–524 for Mupirocin Ointment 2%
because the product is no longer
manufactured or marketed.
SUMMARY:
pmangrum on DSK3GDR082PROD with RULES
[FR Doc. 2017–03678 Filed 2–23–17; 8:45 am]
BILLING CODE 4164–01–P
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2016–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of 18 new animal drug
applications (NADAs) and 2 abbreviated
new animal drug applications
(ANADAs). These withdrawals of
SUMMARY:
File No.
LINCOMIX (lincomycin)/AMPROL PLUS (amprolium
and ethopabate).
approval of NADAs and ANADAs for
antimicrobial drugs of importance to
human medicine that are administered
to food-producing animals in medicated
feed are being made because the
products are no longer manufactured or
marketed. These actions are consistent
with the FDA Center for Veterinary
Medicine’s initiative for the Judicious
Use of Antimicrobials.
Withdrawal of approval is
effective February 24, 2017.
DATES:
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
withdrawing approval of 18 NADAs and
2 ANADAs. These applications were
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 (https://www.fda.gov/downloads/
AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/UCM299624.pdf).
Their withdrawal of approval is
consistent with the FDA Center for
Veterinary Medicine’s initiative for the
Judicious Use of Antimicrobials.
Approval of the following
applications for new animal drugs
administered in medicated feed is being
voluntarily withdrawn at the sponsors’
requests because these products are no
longer manufactured or marketed:
Product name
044–820 ......................................
VerDate Sep<11>2014
14:13 Feb 23, 2017
Jkt 241001
PO 00000
Frm 00009
Fmt 4700
Sponsor
Sfmt 4700
Sponsor
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Feed as the sole ration for 21 consecu058198
tive days. To assure responsible antimicrobial drug use in broiler chickens,
treatment administration must begin on
or before 10 days of age. See
§ 558.355(d) of this chapter for additional required labeling.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of ANADA 200–524, and all
supplements and amendments thereto,
is hereby withdrawn, effective March 6,
2017.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of this
application.
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11509
Zoetis Inc.
333 Portage St.
Kalamazoo, MI 49007 (Zoetis Inc.).
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24FER1
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[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Page 11509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03678]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA-2016-N-0002]
New Animal Drugs; Withdrawal of Approval of a New Animal Drug
Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of an abbreviated new animal drug application (ANADA) at the sponsor's
request because the product is no longer manufactured or marketed.
DATES: Withdrawal of approval is effective March 6, 2017.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Putney, Inc., One Monument Square, Suite
400, Portland, ME 04101 has requested that FDA withdraw approval of
ANADA 200-524 for Mupirocin Ointment 2% because the product is no
longer manufactured or marketed.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of ANADA
200-524, and all supplements and amendments thereto, is hereby
withdrawn, effective March 6, 2017.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of this application.
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03678 Filed 2-23-17; 8:45 am]
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