Determination That TAGAMET (Cimetidine) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 1423-1424 [2015-00116]
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1423
Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices
requires the submitter’s signature, the
name and title of the person signing the
form, as well as the date signed.
Description of Respondents: The
respondents to this collection of
information are firms interested in
exporting U.S.-manufactured food and
cosmetic products to foreign countries
that require export certificates.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA form
number 2
Type of respondent
Cosmetics ................................................
Conventional Food (Including Seafood) ..
Dietary Supplements, Food for Special
Dietary Use, Infant Formula, and Medical Foods .............................................
Food Additives and Food Contact Substances .................................................
Total ..................................................
1 There
rljohnson on DSK3VPTVN1PROD with NOTICES
2 Form
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
3613d
3613e
600
398
1
1
600
398
1.5
1.5
900
597
3613e
2,129
4
2,129
1.5
3,194
3613e
167
1
167
1.5
251
........................
........................
........................
........................
........................
4,942
are no operating and maintenance costs associated with this collection of information.
FDA 3613d and Form FDA 3613e may be submitted electronically via the Certificate Application Process.
For the purpose of this information
collection request, we are basing our
estimate of the average burden per
response in column 6 of Table 1 on the
estimates previously submitted to and
approved by OMB under control
number 0910–0498. Our estimate of the
average burden per response in column
6 of Table 1 varies according to the
product category for which the
certificate is requested. We base our
estimates of the total annual responses
in column 5 of Table 1 on our
experience with certificate applications
received in the past 2 fiscal years. Some
respondents send in requests as often as
three or four times a month while others
may submit only periodic requests.
We expect that most if not all firms
requesting export certificates in the next
3 years will choose to take advantage of
the option of electronic submission via
the CFSAN Certificate Application
Process. Thus, our burden estimates in
Table 1 are based on the expectation of
100 percent participation in the
electronic submission process. The
opportunity to provide the information
in electronic format could reduce the
Agency’s previous estimates for the time
to prepare each submission. However,
as a conservative approach for the
purpose of this analysis, we are
assuming that the opportunity to submit
the information in electronic format will
have no effect on the average time to
prepare a submission.
Dated: January 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–00130 Filed 1–8–15; 8:45 am]
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14:56 Jan 08, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2258]
Determination That TAGAMET
(Cimetidine) Tablets and Other Drug
Products Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Amy Hopkins, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223,
Silver Spring, MD 20993–0002, 301–
796–5418, Amy.Hopkins@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
E:\FR\FM\09JAN1.SGM
09JAN1
1424
Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
(As requested by the applicants, FDA
withdrew approval of NDA 017920 for
TAGAMET (cimetidine) Tablets in the
Federal Register of June 8, 2011 (76 FR
33310), and NDA 018709 for CAPOZIDE
(captopril and hydrochlorothiazide)
Tablets in the Federal Register of March
19, 2012 (77 FR 16039).)
Application No.
Drug
Applicant
NDA 017920 ......
GlaxoSmithKline, 5 Moore Dr., P.O. Box 13398, Research
Triangle Park, NC 27709.
Allergan Inc., 2525 Dupont Dr., Irvine, CA 92623.
NDA 018976 ......
TAGAMET (cimetidine) Tablet; Oral, 200 milligram (mg); 300
mg; 400 mg; 800 mg.
OPTICROM (cromolyn sodium) Solution/Drops; Ophthalmic,
4%.
CAPOZIDE (captopril and hydrochlorothiazide) Tablet; Oral,
25 mg/15 mg; 25 mg/25 mg; 50 mg/15 mg; 50 mg/25 mg.
LEVATOL (penbutolol sulfate) Tablet; Oral, 10 mg; 20 mg ....
NDA 019958 ......
CUTIVATE (fluticasone propionate) Cream; Topical, 0.05% ..
NDA 020713 ......
MIRCETTE (desogestrel and ethinyl estradiol, and ethinyl estradiol) Tablet; Oral-28, 0.15 mg/0.02 mg; 0.01 mg.
AVANDAMET
(metformin
hydrochloride
(HCl)
and
rosiglitazone maleate) Tablet; Oral, 500 mg/Equivalent to 1
mg Base.
IQUIX (levofloxacin) Solution/Drops; Ophthalmic, 1.5% ..........
NIRAVAM (alprazolam) Orally Disintegrating Tablets; Oral,
0.25 mg; 0.5 mg; 1 mg; 2 mg.
FLUDEOXYGLUCLOSE F–18 Injectable; Intravenous 10–100
millicuries/milliliter.
PARCOPA (carbidopa and levodopa) Orally Disintegrating
Tablets; Oral, 10 mg/100 mg; 25 mg/100 mg; 25 mg/250
mg.
ALBALON (naphazoline HCl) Solution/Drops; Ophthalmic,
0.1%.
NDA 018155 ......
NDA 018709 ......
NDA 021410 ......
NDA 021571 ......
NDA 021726 ......
NDA 021768 ......
ANDA 076699 ....
rljohnson on DSK3VPTVN1PROD with NOTICES
ANDA 080248 ....
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs and ANDAs listed in this
document are unaffected by the
discontinued marketing of the products
subject to those NDAs and ANDAs.
Additional ANDAs that refer to these
products may also be approved by the
Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for these
drug products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: January 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–00116 Filed 1–8–15; 8:45 am]
BILLING CODE 4164–01–P
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14:56 Jan 08, 2015
Jkt 235001
Apothecon Inc., P.O. Box 4500, Princeton, NJ 08543.
Auxilium Pharmaceuticals LLC, 640 Lee Rd., Chesterbrook,
PA 19087.
Fougera Pharmaceuticals Inc., 1 Health Plaza, Bldg. 434,
East Hanover, NJ 07936.
Teva Pharmaceutical Products Inc., 41 Moores Rd, P.O. Box
4011, Frazer, PA 19355.
SmithKline Beecham Cork Ltd., Ireland, 2301 Renaissance
Blvd., MC RN 0420, King of Prussia, PA 19406.
Santen Inc., 555 Gateway Dr., Napa, CA 94558.
UCB Inc., 1950 Lake Park Dr., Smyrna, GA 30080.
Weill Medical College Cornell University, 516 East 72nd St.,
New York, NY 10065.
UCB Inc., 1950 Lake Park Dr., Smyrna, GA 30080.
Allergan Inc., 2525 Dupont Dr., Irvine, CA 92623.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1021]
Medical Device User Fee and
Modernization Act; Notice to Public of
Web Site Location of Fiscal Year 2015
Proposed Guidance Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the Web site location where
the Agency will post two lists of
guidance documents that the Center for
Devices and Radiological Health (CDRH
or the Center) is intending to publish in
Fiscal Year (FY) 2015. In addition, FDA
has established a docket, identified in
brackets in the heading of this
document, where stakeholders may
comment on the priority of topics for
guidance, provide comments and/or
propose draft language for those topics,
suggest topics for new or different
guidance documents, and comment on
the applicability of guidance documents
that have issued previously.
DATES: You may submit either electronic
or written comments at any time. FDA
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
would appreciate if stakeholders
provide feedback by March 10, 2015.
ADDRESSES: Submit electronic
comments on the proposed guidance to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
Gadiock, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5452, Silver Spring,
MD 20993–0002, 301–796–5736.
SUPPLEMENTARY INFORMATION:
I. Background
During negotiations over the Medical
Device User Fee Amendments of 2012
(MDUFA III), title II, Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–114), FDA agreed, in
return for additional funding from
industry, to meet a variety of
quantitative and qualitative goals
intended to help get safe and effective
medical devices to market more quickly.
These commitments included:
• Annually posting a list of priority
medical device guidance documents
that the Agency intends to publish
within 12 months of the date this list is
published each fiscal year (the ‘‘A-list’’)
and
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Pages 1423-1424]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00116]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2258]
Determination That TAGAMET (Cimetidine) Tablets and Other Drug
Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that the
drug products listed in this document were not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to the products as
long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Amy Hopkins, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301-
796-5418, Amy.Hopkins@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
[[Page 1424]]
FDA has become aware that the drug products listed in the table in
this document are no longer being marketed. (As requested by the
applicants, FDA withdrew approval of NDA 017920 for TAGAMET
(cimetidine) Tablets in the Federal Register of June 8, 2011 (76 FR
33310), and NDA 018709 for CAPOZIDE (captopril and hydrochlorothiazide)
Tablets in the Federal Register of March 19, 2012 (77 FR 16039).)
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 017920............. TAGAMET (cimetidine) GlaxoSmithKline, 5
Tablet; Oral, 200 Moore Dr., P.O. Box
milligram (mg); 300 13398, Research
mg; 400 mg; 800 mg. Triangle Park, NC
27709.
NDA 018155............. OPTICROM (cromolyn Allergan Inc., 2525
sodium) Solution/ Dupont Dr., Irvine,
Drops; Ophthalmic, 4%. CA 92623.
NDA 018709............. CAPOZIDE (captopril and Apothecon Inc., P.O.
hydrochlorothiazide) Box 4500, Princeton,
Tablet; Oral, 25 mg/15 NJ 08543.
mg; 25 mg/25 mg; 50 mg/
15 mg; 50 mg/25 mg.
NDA 018976............. LEVATOL (penbutolol Auxilium
sulfate) Tablet; Oral, Pharmaceuticals LLC,
10 mg; 20 mg. 640 Lee Rd.,
Chesterbrook, PA
19087.
NDA 019958............. CUTIVATE (fluticasone Fougera
propionate) Cream; Pharmaceuticals Inc.,
Topical, 0.05%. 1 Health Plaza, Bldg.
434, East Hanover, NJ
07936.
NDA 020713............. MIRCETTE (desogestrel Teva Pharmaceutical
and ethinyl estradiol, Products Inc., 41
and ethinyl estradiol) Moores Rd, P.O. Box
Tablet; Oral-28, 0.15 4011, Frazer, PA
mg/0.02 mg; 0.01 mg. 19355.
NDA 021410............. AVANDAMET (metformin SmithKline Beecham
hydrochloride (HCl) Cork Ltd., Ireland,
and rosiglitazone 2301 Renaissance
maleate) Tablet; Oral, Blvd., MC RN 0420,
500 mg/Equivalent to 1 King of Prussia, PA
mg Base. 19406.
NDA 021571............. IQUIX (levofloxacin) Santen Inc., 555
Solution/Drops; Gateway Dr., Napa, CA
Ophthalmic, 1.5%. 94558.
NDA 021726............. NIRAVAM (alprazolam) UCB Inc., 1950 Lake
Orally Disintegrating Park Dr., Smyrna, GA
Tablets; Oral, 0.25 30080.
mg; 0.5 mg; 1 mg; 2 mg.
NDA 021768............. FLUDEOXYGLUCLOSE F-18 Weill Medical College
Injectable; Cornell University,
Intravenous 10-100 516 East 72nd St.,
millicuries/milliliter. New York, NY 10065.
ANDA 076699............ PARCOPA (carbidopa and UCB Inc., 1950 Lake
levodopa) Orally Park Dr., Smyrna, GA
Disintegrating 30080.
Tablets; Oral, 10 mg/
100 mg; 25 mg/100 mg;
25 mg/250 mg.
ANDA 080248............ ALBALON (naphazoline Allergan Inc., 2525
HCl) Solution/Drops; Dupont Dr., Irvine,
Ophthalmic, 0.1%. CA 92623.
------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
Dated: January 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00116 Filed 1-8-15; 8:45 am]
BILLING CODE 4164-01-P
