High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing, 4134-4135 [05-1656]
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Federal Register / Vol. 70, No. 18 / Friday, January 28, 2005 / Notices
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[FR Doc. 05–1503 Filed 1–27–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0010]
High Chemical Co. et al.; Proposal to
Withdraw Approval of 13 New Drug
Applications; Opportunity for a
Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for a hearing on the
agency’s proposal to withdraw approval
of 13 new drug applications (NDAs)
from multiple sponsors. The basis for
the proposal is that the sponsors have
repeatedly failed to file required annual
reports for these applications.
DATES: Submit written requests for a
hearing by February 28, 2005; submit
data and information in support of the
hearing request by March 29, 2005.
ADDRESSES: Requests for a hearing,
supporting data, and other comments
are to be identified with Docket No.
2005N–0010 and submitted to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
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
§ 314.81 (21 CFR 314.81). The holders of
the approved applications listed in the
following table have failed to submit the
required annual reports and have not
responded to the agency’s request by
certified mail for submission of the
reports.
E:\FR\FM\28JAN1.SGM
28JAN1
Federal Register / Vol. 70, No. 18 / Friday, January 28, 2005 / Notices
Application No.
Drug
4135
Applicant
NDA 0–763
Sterile Solution Procaine Injection 2% (Procaine Hydrochloride (HCl))
High Chemical Co., 1760 N. Howard St.,
Philadelphia, PA 19122
NDA 2–959
Nicotinic Acid (Niacin) Tablets
The Blue Line Chemical Co., 302 South
Broadway, St. Louis, MO 63102
NDA 4–236
Sherman (thiamine HCl) Elixir
Do.
NDA 4–368
Ascorbic Acid Tablets
Do.
NDA 5–159
D.S.D. (diethylstilbestrol dipropionate)
Do.
NDA 9–452
Multifuge (piperazine citrate) Syrup
Do.
NDA 10–055
Fire Gard Three-Alarm Burn Relief
(Methylcellulose)
Gard Products, Inc., 2560 Tara Lane, Brunswick, GA 31520
NDA 10–337
Fling Antiperspirant Foot Powder
Bauer & Black, A Division of The Kendall
Co., One Federal St., Boston, MA 02110
NDA 10–541
BY–NA–MID (Butylphenamide or B and Zinc
Oxide or Stearate) Tincture, Ointment, Lotion, and Powder
Miles Inc., Cutter Biological, P.O. Box 1986,
Berkeley, CA 94701
NDA 10–823
BIKE Foot and Body Powder
Bauer & Black, A Division of The Kendall Co.
NDA 10–824
BIKE Anti-Fungal Aerosol Spray
Do.
NDA 11–233
TKO with Entrin Roll-On Liquid
Modern-Labs, Inc., Maple Rd., Gambrills, MD
21504
NDA 19–432
Spectamine (Iofetamine Hydrochloride I–123)
Injection
IMP Inc., 8050 El Rio, Houston, TX 77054
Therefore, notice is given to the
holders of the approved applications
listed in the table and to all other
interested persons that the Director of
the Center for Drug Evaluation and
Research proposes to issue an order
under section 505(e) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 355(e)) withdrawing approval
of the applications and all amendments
and supplements thereto on the ground
that the applicants have failed to submit
reports required under § 314.81.
In accordance with section 505 of the
act and 21 CFR part 314, the applicants
are hereby provided an opportunity for
a hearing to show why the applications
listed previously should not be
withdrawn and an opportunity to raise,
for administrative determination, all
issues relating to the legal status of the
drug products covered by these
applications.
An applicant who decides to seek a
hearing shall file: (1) A written notice of
participation and request for a hearing
(see DATES) and (2) the data,
information, and analyses relied on to
demonstrate that there is a genuine and
substantial issue of fact that requires a
hearing (see DATES). Any other
interested person may also submit
comments on this document. The
procedures and requirements governing
this notice of opportunity for a hearing,
VerDate jul<14>2003
15:43 Jan 27, 2005
Jkt 205001
notice of participation and request for a
hearing, information and analyses to
justify a hearing, other comments, and
a grant or denial of a hearing are
contained in § 314.200 and 21 CFR part
12.
The failure of an applicant to file a
timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by that
applicant not to avail itself of the
opportunity for a hearing concerning the
proposal to withdraw approval of the
applications and constitutes a waiver of
any contentions concerning the legal
status of the drug products. FDA will
then withdraw approval of the
applications and the drug products may
not thereafter lawfully be marketed, and
FDA will begin appropriate regulatory
action to remove the products from the
market. Any new drug product
marketed without an approved NDA is
subject to regulatory action at any time.
A request for a hearing may not rest
upon mere allegations or denials, but
must present specific facts showing that
there is a genuine and substantial issue
of fact that requires a hearing. Reports
submitted to remedy the deficiencies
must be complete in all respects in
accordance with § 314.81. If the
submission is not complete or if a
request for a hearing is not made in the
required format or with the required
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
reports, the Commissioner of Food and
Drugs (the Commissioner) will enter
summary judgment against the person
who requests the hearing, making
findings and conclusions, and denying
a hearing.
All submissions under this notice of
opportunity for a hearing must be filed
in four copies. Except for data and
information prohibited from public
disclosure under section 301 of the act
(21 U.S.C. 331(j)) or 18 U.S.C. 1905, the
submissions may be seen in the Division
of Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday.
This notice is issued under the act
(section 505 (21 U.S.C. 355)) and under
authority delegated to the Director,
Center for Drug Evaluation and
Research, by the Commissioner.
Dated: January 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–1656 Filed 1–27–05; 8:45 am]
BILLING CODE 4160–01–S
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28JAN1
]]>Agencies
[Federal Register Volume 70, Number 18 (Friday, January 28, 2005)]
[Notices]
[Pages 4134-4135]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1656]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0010]
High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New
Drug Applications; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for a hearing on the agency's proposal to withdraw approval
of 13 new drug applications (NDAs) from multiple sponsors. The basis
for the proposal is that the sponsors have repeatedly failed to file
required annual reports for these applications.
DATES: Submit written requests for a hearing by February 28, 2005;
submit data and information in support of the hearing request by March
29, 2005.
ADDRESSES: Requests for a hearing, supporting data, and other comments
are to be identified with Docket No. 2005N-0010 and submitted to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
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). The holders of the approved applications
listed in the following table have failed to submit the required annual
reports and have not responded to the agency's request by certified
mail for submission of the reports.
[[Page 4135]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 0-763 Sterile Solution High Chemical Co.,
Procaine Injection 2% 1760 N. Howard St.,
(Procaine Philadelphia, PA
Hydrochloride (HCl)) 19122
------------------------------------------------------------------------
NDA 2-959 Nicotinic Acid (Niacin) The Blue Line Chemical
Tablets Co., 302 South
Broadway, St. Louis,
MO 63102
------------------------------------------------------------------------
NDA 4-236 Sherman (thiamine HCl) Do.
Elixir
------------------------------------------------------------------------
NDA 4-368 Ascorbic Acid Tablets Do.
------------------------------------------------------------------------
NDA 5-159 D.S.D. Do.
(diethylstilbestrol
dipropionate)
------------------------------------------------------------------------
NDA 9-452 Multifuge (piperazine Do.
citrate) Syrup
------------------------------------------------------------------------
NDA 10-055 Fire Gard Three-Alarm Gard Products, Inc.,
Burn Relief 2560 Tara Lane,
(Methylcellulose) Brunswick, GA 31520
------------------------------------------------------------------------
NDA 10-337 Fling Antiperspirant Bauer & Black, A
Foot Powder Division of The
Kendall Co., One
Federal St., Boston,
MA 02110
------------------------------------------------------------------------
NDA 10-541 BY-NA-MID Miles Inc., Cutter
(Butylphenamide or B Biological, P.O. Box
and Zinc Oxide or 1986, Berkeley, CA
Stearate) Tincture, 94701
Ointment, Lotion, and
Powder
------------------------------------------------------------------------
NDA 10-823 BIKE Foot and Body Bauer & Black, A
Powder Division of The
Kendall Co.
------------------------------------------------------------------------
NDA 10-824 BIKE Anti-Fungal Do.
Aerosol Spray
------------------------------------------------------------------------
NDA 11-233 TKO with Entrin Roll-On Modern-Labs, Inc.,
Liquid Maple Rd., Gambrills,
MD 21504
------------------------------------------------------------------------
NDA 19-432 Spectamine (Iofetamine IMP Inc., 8050 El Rio,
Hydrochloride I-123) Houston, TX 77054
Injection
------------------------------------------------------------------------
Therefore, notice is given to the holders of the approved
applications listed in the table and to all other interested persons
that the Director of the Center for Drug Evaluation and Research
proposes to issue an order under section 505(e) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) withdrawing
approval of the applications and all amendments and supplements thereto
on the ground that the applicants have failed to submit reports
required under Sec. 314.81.
In accordance with section 505 of the act and 21 CFR part 314, the
applicants are hereby provided an opportunity for a hearing to show why
the applications listed previously should not be withdrawn and an
opportunity to raise, for administrative determination, all issues
relating to the legal status of the drug products covered by these
applications.
An applicant who decides to seek a hearing shall file: (1) A
written notice of participation and request for a hearing (see DATES)
and (2) the data, information, and analyses relied on to demonstrate
that there is a genuine and substantial issue of fact that requires a
hearing (see DATES). Any other interested person may also submit
comments on this document. The procedures and requirements governing
this notice of opportunity for a hearing, notice of participation and
request for a hearing, information and analyses to justify a hearing,
other comments, and a grant or denial of a hearing are contained in
Sec. 314.200 and 21 CFR part 12.
The failure of an applicant to file a timely written notice of
participation and request for a hearing, as required by Sec. 314.200,
constitutes an election by that applicant not to avail itself of the
opportunity for a hearing concerning the proposal to withdraw approval
of the applications and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the applications and the drug products may not
thereafter lawfully be marketed, and FDA will begin appropriate
regulatory action to remove the products from the market. Any new drug
product marketed without an approved NDA is subject to regulatory
action at any time.
A request for a hearing may not rest upon mere allegations or
denials, but must present specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing. Reports
submitted to remedy the deficiencies must be complete in all respects
in accordance with Sec. 314.81. If the submission is not complete or
if a request for a hearing is not made in the required format or with
the required reports, the Commissioner of Food and Drugs (the
Commissioner) will enter summary judgment against the person who
requests the hearing, making findings and conclusions, and denying a
hearing.
All submissions under this notice of opportunity for a hearing must
be filed in four copies. Except for data and information prohibited
from public disclosure under section 301 of the act (21 U.S.C. 331(j))
or 18 U.S.C. 1905, the submissions may be seen in the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
This notice is issued under the act (section 505 (21 U.S.C. 355))
and under authority delegated to the Director, Center for Drug
Evaluation and Research, by the Commissioner.
Dated: January 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1656 Filed 1-27-05; 8:45 am]
BILLING CODE 4160-01-S
