Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone; Tylosin, 60442 [2012-24330]
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60442
Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Notices
for public review in the Division of
Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[Docket No. FDA–2012–N–0981]
applications (ANADAs) at the sponsors’
request because the products are no
longer manufactured or marketed.
Food and Drug Administration
Withdrawal of approval is
effective October 15, 2012.
DATES:
Withdrawal of Approval of New Animal
Drug Applications; Butorphanol;
Doxapram; Triamcinolone; Tylosin
[FR Doc. 2012–24213 Filed 10–2–12; 8:45 am]
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6843,
email: david.alterman@fda.hhs.gov.
The
following sponsors have requested that
FDA withdraw approval of the NADA
and ANADAs listed in table 1 of this
document because the products are no
longer manufactured or marketed.
SUPPLEMENTARY INFORMATION:
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) and three
abbreviated new animal drug
SUMMARY:
TABLE 1—NADA AND ANADAS FOR WHICH WITHDRAWAL OF APPROVAL HAS BEEN REQUESTED
NADA/ANADA No.
Trade name (drug)
Applicant
100–556 ...............................
Vigorena Feeds Hy-Ty Premix (tylosin phosphate) ........
200–435 ...............................
RESPIRAM (doxapram hydrochloride) Injection .............
200–446 ...............................
BUTORPHINE (butorphanol tartrate) Injection ...............
200–459 ...............................
VETAZINE (triamcinolone) Cream ..................................
Springfield Milling Corp., Vigorena Feeds, Springfield,
MN 56087.
Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., Suite 317, Miami, FL 33157.
Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., Suite 317, Miami, FL 33157.
Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., Suite 317, Miami, FL 33157.
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 NADA 100–556 and ANADAs 200–
435, 200–446, and 200–459, and all
supplements and amendments thereto,
is hereby withdrawn, effective October
15, 2012.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: September 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–24330 Filed 10–2–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
erowe on DSK2VPTVN1PROD with
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
VerDate Mar<15>2010
18:36 Oct 02, 2012
Jkt 229001
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
A Novel Immortalized Human Adrenal
Cell Line With Inactive Protein Kinase
A for Studies on cAMP Signaling and
Endocrine Tumorigenesis
Description of Technology: The first
known immortalized cell line with a
naturally-occurring inactivating
mutation in PRKAR1A, the regulatory
subunit type 1A (R1alpha) of protein
PO 00000
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Fmt 4703
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kinase A (PKA), which is associated
with tumor formation.
PKA isozyme balance is critical for
the control of cAMP signaling and
related cell cycle and proliferation
changes. Aberrant cAMP signaling has
been linked to adrenocortical and other,
mostly endocrine, tumors. Inactivating
mutations in the PRKAR1A gene are a
known cause of Carney Complex—an
autosomal dominant multiple neoplasia
syndrome associated with skin, heart,
and other myxomas and a variety of
endocrine tumors.
Potential Commercial Applications:
• Studies on multiple tumor
formation associated with Carney
Complex.
• Characterization of cAMP-mediated
mechanisms of endocrine tumor
formation.
• Studies of a large variety of cAMPmediated processes in normal
physiology and disease.
Competitive Advantages: First known
immortalized cell line with a naturallyoccurring inactivating mutation in the
PRKAR1A gene.
Development Stage: In vitro data
available.
Inventor: Constantine A. Stratakis
(NICHD).
Publication: Nesterova M, et al. An
immortalized human cell line bearing a
PRKAR1A-inactivating mutation: effects
of overexpression of the wild-type
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Page 60442]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24330]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0981]
Withdrawal of Approval of New Animal Drug Applications;
Butorphanol; Doxapram; Triamcinolone; Tylosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new animal drug application (NADA) and three abbreviated new
animal drug applications (ANADAs) at the sponsors' request because the
products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective October 15, 2012.
FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6843, email: david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the NADA and ANADAs listed in table 1 of this
document because the products are no longer manufactured or marketed.
Table 1--NADA and ANADAs for Which Withdrawal of Approval Has Been
Requested
------------------------------------------------------------------------
NADA/ANADA No. Trade name (drug) Applicant
------------------------------------------------------------------------
100-556..................... Vigorena Feeds Hy-Ty Springfield Milling
Premix (tylosin Corp., Vigorena
phosphate). Feeds, Springfield,
MN 56087.
200-435..................... RESPIRAM (doxapram Modern Veterinary
hydrochloride) Therapeutics, LLC,
Injection. 18001 Old Cutler
Rd., Suite 317,
Miami, FL 33157.
200-446..................... BUTORPHINE Modern Veterinary
(butorphanol Therapeutics, LLC,
tartrate) Injection. 18001 Old Cutler
Rd., Suite 317,
Miami, FL 33157.
200-459..................... VETAZINE Modern Veterinary
(triamcinolone) Therapeutics, LLC,
Cream. 18001 Old Cutler
Rd., Suite 317,
Miami, FL 33157.
------------------------------------------------------------------------
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 NADA
100-556 and ANADAs 200-435, 200-446, and 200-459, and all supplements
and amendments thereto, is hereby withdrawn, effective October 15,
2012.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: September 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-24330 Filed 10-2-12; 8:45 am]
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