Smith Miller and Patch, Inc. et al.; Withdrawal of Approval of 14 New Drug Applications, 68454-68455 [2014-27039]
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68454
Federal Register / Vol. 79, No. 221 / Monday, November 17, 2014 / Notices
IV. Electronic Access
Persons with access to the Internet
may obtain the document at: https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/default.htm, or https://
www.regulations.gov.
Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–27022 Filed 11–14–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1285]
Smith Miller and Patch, Inc. et al.;
Withdrawal of Approval of 14 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 14 new drug applications
(NDAs) from multiple holders of these
applications. The basis for the
withdrawals is that the holders of the
applications have repeatedly failed to
file required annual reports for the
applications.
DATES: November 17, 2014.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUMMARY:
The
holders of approved applications to
market new drugs for human use are
required to submit annual reports to
FDA concerning each of their approved
applications in accordance with
§ 314.81 (21 CFR 314.81).
In the Federal Register of November
6, 2013 (78 FR 66748), FDA published
a notice offering an opportunity for a
hearing (NOOH) on a proposal to
withdraw approval of 14 NDAs because
the firms had failed to submit the
required annual reports for these
applications. The holders of these
applications did not respond to the
NOOH. Failure to file a written notice
of participation and request for hearing
as required by § 314.200 (21 CFR
314.200) constitutes an election by the
applicant not to make use of the
opportunity for a hearing concerning the
proposal to withdraw approval of the
applications and a waiver of any
contentions concerning the legal status
of the drug products. Therefore, the
Director, Center for Drug Evaluation and
Research, is withdrawing approval of
the 14 applications listed in table 1 of
this document.
SUPPLEMENTARY INFORMATION:
TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Drug
Applicant
NDA 004979 ..............
Multi-Vitamin Tablets ............................................................
NDA 008176 ..............
NDA 008326 ..............
NDA 008362 ..............
Methostan (methandriol) Tablets .........................................
Methischol (inositol/vitamin B12/racemethionine/choline
chloride) Injection.
Corticotropin Injection ..........................................................
NDA 009346 ..............
NDA 009515 ..............
ACTH (corticotropin) Injection ..............................................
Hyrye (riboflavin 5′-phosphate sodium) Injection .................
NDA 010415 ..............
Flamotide (riboflavin 5′-phosphate sodium) Injection ..........
NDA 010565 ..............
Duracton (corticotropin) Injection .........................................
NDA 010791 ..............
Rubivite (cyanocobalamin) Injection ....................................
NDA 010831 ..............
Corticotropin Injection ..........................................................
NDA 011015 ..............
RU–B–12–1000 (cyanocobalamin) Injection ........................
NDA 011578 ..............
Efacin (niacin) Tablet ...........................................................
NDA 017861 ..............
Acthar Gel Synthetic (seractide acetate) Injection ..............
NDA 018087 ..............
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Application No.
Thyrel TRH (protirelin) Injection ...........................................
Smith Miller and Patch Inc., P.O. Box 367, San German,
PR 00753.
Do.
USV Pharmaceutical Corp., 500 Virginia Dr., Fort Washington, PA 19034–2779.
Vitarine Pharmaceuticals Inc., 227–15 North Conduit Ave.,
Springfield Gardens, NY 11413.
Parke-Davis, 201 Tabor Rd., Morris Plains, NJ 07950.
S.F. Durst and Co., Inc., 5317–21 North Third St., Philadelphia, PA 19120.
Philadelphia Ampoule Laboratories, 400 Green St., Philadelphia, PA 19123.
Nordic Biochemicals Inc., 45 Bay State Rd., Boston, MA
02215.
Bel Mar Laboratories, Inc., 6–10 Nassau Ave., Inwood, NY
11696.
Organics/LaGrange, Inc., 1935 Techny Rd., suite 14,
Northbrook, IL 60062.
Dow Pharmaceutical Corp., 9550 North Zionsville Rd., Indianapolis, IN 46268.
Person and Covey, Inc., 616 Allen Ave., Glendale, CA
91201.
Armour Pharmaceutical Co., P.O. Box 511, Kankakee, IL
60901.
Ferring Pharmaceuticals, Inc., 400 Rella Blvd., suite 300,
Suffern, NY 10901.
The Director, Center for Drug
Evaluation and Research, under section
505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)), and
under authority delegated by the
Commissioner, finds that the holders of
the applications listed in this document
VerDate Sep<11>2014
17:14 Nov 14, 2014
Jkt 235001
have repeatedly failed to submit reports
required by § 314.81. In addition, under
§ 314.200, we find that the holders of
the applications have waived any
contentions concerning the legal status
of the drug products. Therefore, under
these findings, approval of the
PO 00000
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Fmt 4703
Sfmt 4703
applications listed in this document,
and all amendments and supplements
thereto, is hereby withdrawn, effective
November 17, 2014.
E:\FR\FM\17NON1.SGM
17NON1
Federal Register / Vol. 79, No. 221 / Monday, November 17, 2014 / Notices
Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–27039 Filed 11–14–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Advisory Commission on Childhood
Vaccines; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: Advisory Commission on
Childhood Vaccines (ACCV)
Date And Time: December 4, 2014,
10:00 a.m. to 4:00 p.m. EDT
Place: Audio Conference Call and
Adobe Connect Pro
The ACCV will meet on Thursday,
December 4, 2014, from 10:00 a.m. to
4:00 p.m. (EDT). The public can join the
meeting by:
1. (Audio Portion) Calling the
conference Phone Number 877–917–
4913 and providing the following
information:
Leader’s Name: Dr. A. Melissa Houston
Password: ACCV
2. (Visual Portion) Connecting to the
ACCV Adobe Connect Pro Meeting
using the following URL: https://
hrsa.connectsolutions.com/accv/ (copy
and paste the link into your browser if
it does not work directly, and enter as
a guest). Participants should call and
connect 15 minutes prior to the meeting
in order for logistics to be set up. If you
have never attended an Adobe Connect
meeting, please test your connection
using the following URL: https://
hrsa.connectsolutions.com/common/
help/en/support/meeting_test.htm and
get a quick overview by following URL:
https://www.adobe.com/go/connectpro_
overview. Call (301) 443–6634 or send
an email to aherzog@hrsa.gov if you are
having trouble connecting to the
meeting site.
Agenda: The agenda items for the
December 2014 meeting will include,
but are not limited to: updates from the
Division of Injury Compensation
Programs (DICP), Department of Justice
(DOJ), National Vaccine Program Office
(NVPO), Immunization Safety Office
(Centers for Disease Control and
Prevention), National Institute of
Allergy and Infectious Diseases
(National Institutes of Health), and the
Center for Biologics, Evaluation and
Research (Food and Drug
VerDate Sep<11>2014
17:14 Nov 14, 2014
Jkt 235001
Administration). A draft agenda and
additional meeting materials will be
posted on the ACCV Web site (https://
www.hrsa.gov/vaccinecompensation/
accv.htm) prior to the meeting. Agenda
items are subject to change as priorities
dictate.
Public Comment: Persons interested
in providing an oral presentation should
submit a written request, along with a
copy of their presentation to: Annie
Herzog, DICP, Healthcare Systems
Bureau (HSB), Health Resources and
Services Administration (HRSA), Room
11C–26, 5600 Fishers Lane, Rockville,
MD 20857 or email: aherzog@hrsa.gov.
Requests should contain the name,
address, telephone number, email
address, and any business or
professional affiliation of the person
desiring to make an oral presentation.
Groups having similar interests are
requested to combine their comments
and present them through a single
representative. The allocation of time
may be adjusted to accommodate the
level of expressed interest. DVIC will
notify each presenter by email, mail, or
telephone of their assigned presentation
time. Persons who do not file an
advance request for a presentation, but
desire to make an oral statement, may
announce it at the time of the public
comment period. Public participation
and ability to comment will be limited
to space and time as it permits.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the ACCV should contact Annie Herzog,
DICP, HSB, HRSA, Room 11C–26, 5600
Fishers Lane, Rockville, Maryland
20857, telephone (301) 443–6593, or
email: aherzog@hrsa.gov.
Dated: November 7, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–27188 Filed 11–14–14; 8:45 am]
BILLING CODE 6705–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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. 209 and 37 CFR Part 404 to
achieve expeditious commercialization
SUMMARY:
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Fmt 4703
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68455
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.
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.
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
Heterocyclic Compounds for the
Treatment of Hepatitis C Virus
Description of Technology: The vast
majority of people infected with
Hepatitis C Virus (HCV) will have
chronic infection. Over decades, this
can lead to liver disease and liver
cancer. In fact, HCV infection is the
leading cause of liver transplants in the
U.S. Several new drugs have recently
come into the market that have changed
the HCV treatment paradigm. However,
the effectiveness of these new drugs can
vary depending on the HCV genotype.
Furthermore, all oral, interferon free
therapeutic regimens for HCV infection
will need combinations of drugs that
target different aspects of the HCV life
cycle. Thus, there is still the need for
additional new therapeutics against
HCV.
The subject technologies are
aryloxazole based small molecules that
are potent inhibitors of HCV infection
and replication. The compounds exhibit
synergy with currently available
therapeutics for HCV and represent a
new class of anti-HCV compounds. The
compounds affect the entry step of HCV
infection, a step not targeted by
currently available therapeutics against
HCV.
Potential Commercial Applications:
Prevention and treatment of HCV
infection.
Competitive Advantages:
• Potent inhibitors of HCV infection
and replication.
• Show synergistic effect with
currently available HCV therapeutics.
• Represent new class of HCV
inhibitors that target the entry step of
HCV infection.
Development Stage:
• Early-stage.
• In vitro data available.
E:\FR\FM\17NON1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 221 (Monday, November 17, 2014)]
[Notices]
[Pages 68454-68455]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27039]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1285]
Smith Miller and Patch, Inc. et al.; Withdrawal of Approval of 14
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 14 new drug applications (NDAs) from multiple holders of these
applications. The basis for the withdrawals is that the holders of the
applications have repeatedly failed to file required annual reports for
the applications.
DATES: November 17, 2014.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new drugs for human use are required to submit annual reports to
FDA concerning each of their approved applications in accordance with
Sec. 314.81 (21 CFR 314.81).
In the Federal Register of November 6, 2013 (78 FR 66748), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of 14 NDAs because the firms had failed
to submit the required annual reports for these applications. The
holders of these applications did not respond to the NOOH. Failure to
file a written notice of participation and request for hearing as
required by Sec. 314.200 (21 CFR 314.200) constitutes an election by
the applicant not to make use of the opportunity for a hearing
concerning the proposal to withdraw approval of the applications and a
waiver of any contentions concerning the legal status of the drug
products. Therefore, the Director, Center for Drug Evaluation and
Research, is withdrawing approval of the 14 applications listed in
table 1 of this document.
Table 1--Approved NDAs for Which Required Reports Have Not Been
Submitted
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 004979.................... Multi-Vitamin Smith Miller and
Tablets. Patch Inc., P.O.
Box 367, San
German, PR 00753.
NDA 008176.................... Methostan Do.
(methandriol)
Tablets.
NDA 008326.................... Methischol USV Pharmaceutical
(inositol/vitamin Corp., 500
B12/racemethionine/ Virginia Dr., Fort
choline chloride) Washington, PA
Injection. 19034-2779.
NDA 008362.................... Corticotropin Vitarine
Injection. Pharmaceuticals
Inc., 227-15 North
Conduit Ave.,
Springfield
Gardens, NY 11413.
NDA 009346.................... ACTH Parke-Davis, 201
(corticotropin) Tabor Rd., Morris
Injection. Plains, NJ 07950.
NDA 009515.................... Hyrye (riboflavin S.F. Durst and Co.,
5'-phosphate Inc., 5317-21
sodium) Injection. North Third St.,
Philadelphia, PA
19120.
NDA 010415.................... Flamotide Philadelphia
(riboflavin 5'- Ampoule
phosphate sodium) Laboratories, 400
Injection. Green St.,
Philadelphia, PA
19123.
NDA 010565.................... Duracton Nordic Biochemicals
(corticotropin) Inc., 45 Bay State
Injection. Rd., Boston, MA
02215.
NDA 010791.................... Rubivite Bel Mar
(cyanocobalamin) Laboratories,
Injection. Inc., 6-10 Nassau
Ave., Inwood, NY
11696.
NDA 010831.................... Corticotropin Organics/LaGrange,
Injection. Inc., 1935 Techny
Rd., suite 14,
Northbrook, IL
60062.
NDA 011015.................... RU-B-12-1000 Dow Pharmaceutical
(cyanocobalamin) Corp., 9550 North
Injection. Zionsville Rd.,
Indianapolis, IN
46268.
NDA 011578.................... Efacin (niacin) Person and Covey,
Tablet. Inc., 616 Allen
Ave., Glendale, CA
91201.
NDA 017861.................... Acthar Gel Armour
Synthetic Pharmaceutical
(seractide Co., P.O. Box 511,
acetate) Injection. Kankakee, IL
60901.
NDA 018087.................... Thyrel TRH Ferring
(protirelin) Pharmaceuticals,
Injection. Inc., 400 Rella
Blvd., suite 300,
Suffern, NY 10901.
------------------------------------------------------------------------
The Director, Center for Drug Evaluation and Research, under
section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(e)), and under authority delegated by the Commissioner, finds that
the holders of the applications listed in this document have repeatedly
failed to submit reports required by Sec. 314.81. In addition, under
Sec. 314.200, we find that the holders of the applications have waived
any contentions concerning the legal status of the drug products.
Therefore, under these findings, approval of the applications listed in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective November 17, 2014.
[[Page 68455]]
Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-27039 Filed 11-14-14; 8:45 am]
BILLING CODE 4164-01-P
