Determination That DRIXORAL (Dexbrompheniramine Maleate; Pseudoephedrine Sulfate) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 47648-47649 [2014-19272]
Download as PDF
<![CDATA[
47648
Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
113.100 and 114.100 ...........................................................
10,392
1
10,392
250
2,598,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of 10,392
recordkeepers in table 2 on its records
of the number of registered firms,
excluding firms that were inactive or
out of business, yet still registered. To
avoid double-counting, we have not
included estimates for § 108.25(e), (g),
and (h) because they merely crossreference recordkeeping requirements
contained in parts 113 and 114 and have
been accounted for in the recordkeeping
burden estimate. We estimate that
10,392 firms will expend approximately
250 hours per year to fully satisfy the
recordkeeping requirements in parts
108, 113 and 114, for a total of 2,598,000
hours.
Finally, our regulations require that
processors mark thermally processed
low-acid foods in hermetically sealed
containers (§ 113.60(c)) and acidified
foods (§ 114.80(b) (21 CFR 114.80(b))
with an identifying code to permit lots
to be traced after distribution. We seek
OMB approval of the third party
disclosure requirements in §§ 113.60(c)
and 114.80(b). However, we have not
included a separate table to report the
estimated burden of these regulations.
No burden has been estimated for the
third party disclosure requirements in
§§ 113.60(c) and 114.80(b) because the
coding process is done as a usual and
customary part of normal business
activities. Coding is a business practice
in foods for liability purposes, inventory
control, and process control in the event
of a problem. Under 5 CFR 1320.3(b)(2)),
the time, effort, and financial resources
necessary to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of activities.
Dated: August 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–19241 Filed 8–13–14; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1139]
Determination That DRIXORAL
(Dexbrompheniramine Maleate;
Pseudoephedrine Sulfate) Tablet 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
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.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
Application No.
Drug
Applicant
NDA 013483 ..............
DRIXORAL
(dexbrompheniramine
maleate
and
pseudoephedrine sulfate) Tablet, Extended Release;
Oral, 6 milligrams (mg)/120 mg.
AVENTYL (nortriptyline hydrochloride (HCl)) Solution; Oral,
Equivalent to (EQ) 10 mg Base/5mL.
MSD Consumer Care Inc., 556 Morris Ave., Summit, NJ
07901.
NDA 014685 ..............
VerDate Mar<15>2010
16:42 Aug 13, 2014
Jkt 232001
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Ranbaxy Pharmaceuticals Inc., 600 College Rd. East,
Princeton, NJ 08540.
E:\FR\FM\14AUN1.SGM
14AUN1
Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
47649
Application No.
Drug
Applicant
NDA 016418 ..............
INDERAL (propranolol HCl) Tablet; Oral, 80 mg .................
NDA 016909 ..............
LIDEX (fluocinonide) Ointment; Topical 0.05% ...................
NDA 017373 ..............
NDA 020073 ..............
LIDEX (fluocinonide) Gel; Topical 0.05% ............................
ROMAZICON (flumazenil) Injectable; Injection, 1 mg/10
milliliters (mL) (0.1 mg/mL); 0.5 mg/5 mL (0.1 mg/mL).
LEUSTATIN (cladribine) Injectable; Injection, 1 mg/mL ......
Wyeth Pharmaceuticals Inc., C/O Pfizer Inc., 235 East
42nd St., New York, NY 10017.
County Line Pharmaceuticals, LLC, 13890 Bishop’s Dr.,
Suite 410, Brookfield, WI 53005.
.....Do.
Hoffmann-La Roche Inc., C/O Genentech Inc., 1 DNA
Way, South San Francisco, CA 94080–4990.
Janssen Pharmaceuticals Inc., C/O Johnson and Johnson
Pharmaceutical Research and Development LLC, 920
Rt. 202 South, P.O. Box 300, Raritan, NJ 08869.
Abbott Laboratories Pharmaceutical Products Division,
Dept. 491 AP6B 1, Abbott Park, IL 60064.
Merck and Co. Inc., 126 East Lincoln Ave., RY 33 212,
P.O. Box 2000, Rahway, NJ 07065–0900.
NDA 020229 ..............
NDA 020347 ..............
NDA 020560 ..............
NDA 020813 ..............
NDA 021046 ..............
NDA 022246 ..............
NDA 050533 ..............
HYTRIN (terazosin HCl) Capsule; Oral, EQ 1 mg Base;
EQ 2 mg Base; EQ 5 mg Base; EQ 10 mg Base.
FOSAMAX (alendronate sodium) Tablet; Oral, EQ 5 mg
Base; EQ 10 mg Base; EQ 35 mg Base; EQ 40 mg
Base.
KLONOPIN (clonazepam) Tablet, Orally Disintegrating
Tablet (ODT); Oral, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, 2
mg.
CELEXA (citalopram hydrobromide) Solution; Oral, EQ 10
mg Base/5 mL.
METOZOLV ODT (metoclopramide HCl) Tablet, ODT;
Oral, EQ 10 mg Base.
VIBRA–TABS (doxycycline hyclate) Tablet; Oral, EQ 100
mg Base.
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 listed in this document are
unaffected by the discontinued
marketing of the products subject to
those NDAs. 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: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2014–19272 Filed 8–13–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Mar<15>2010
16:42 Aug 13, 2014
Jkt 232001
Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ
07110.
Forest Laboratories Inc., Harborside Financial Center,
Plaza V, Suite 1900, Jersey City, NJ 07311.
Salix Pharmaceuticals Inc., 8510 Colonnade Center Dr.,
Raleigh, NC 27615.
Pfizer Laboratories Inc., 235 East 42nd St., New York, NY
10017.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0092]
Guidance for Industry on
Immunogenicity Assessment for
Therapeutic Protein Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Immunogenicity Assessment for
Therapeutic Protein Products.’’
Therapeutic protein products may elicit
immune responses, which may lead to
serious or life-threatening adverse
events for the patient or loss of efficacy
of the product. This guidance is
intended to assist manufacturers and
clinical investigators in developing a
risk-based approach in both the
nonclinical and clinical phases of
product development that will allow
them to evaluate and reduce the
likelihood that the immunogenicity of
the product will cause harm to patients.
This guidance finalizes the draft
guidance issued in February 2013.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
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:
Amy Rosenberg, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 2238,
Silver Spring, MD 20892, 240–402–
9789; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Rockville, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Immunogenicity Assessment for
Therapeutic Protein Products.’’ The
purpose of this guidance is to assist
E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47648-47649]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19272]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1139]
Determination That DRIXORAL (Dexbrompheniramine Maleate;
Pseudoephedrine Sulfate) Tablet 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.
FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 013483.................... DRIXORAL MSD Consumer Care
(dexbrompheniramin Inc., 556 Morris
e maleate and Ave., Summit, NJ
pseudoephedrine 07901.
sulfate) Tablet,
Extended Release;
Oral, 6 milligrams
(mg)/120 mg.
NDA 014685.................... AVENTYL Ranbaxy
(nortriptyline Pharmaceuticals
hydrochloride Inc., 600 College
(HCl)) Solution; Rd. East,
Oral, Equivalent Princeton, NJ
to (EQ) 10 mg Base/ 08540.
5mL.
[[Page 47649]]
NDA 016418.................... INDERAL Wyeth
(propranolol HCl) Pharmaceuticals
Tablet; Oral, 80 Inc., C/O Pfizer
mg. Inc., 235 East
42nd St., New
York, NY 10017.
NDA 016909.................... LIDEX County Line
(fluocinonide) Pharmaceuticals,
Ointment; Topical LLC, 13890
0.05%. Bishop's Dr.,
Suite 410,
Brookfield, WI
53005.
NDA 017373.................... LIDEX .....Do.
(fluocinonide)
Gel; Topical 0.05%.
NDA 020073.................... ROMAZICON Hoffmann-La Roche
(flumazenil) Inc., C/O
Injectable; Genentech Inc., 1
Injection, 1 mg/10 DNA Way, South San
milliliters (mL) Francisco, CA
(0.1 mg/mL); 0.5 94080-4990.
mg/5 mL (0.1 mg/
mL).
NDA 020229.................... LEUSTATIN Janssen
(cladribine) Pharmaceuticals
Injectable; Inc., C/O Johnson
Injection, 1 mg/mL. and Johnson
Pharmaceutical
Research and
Development LLC,
920 Rt. 202 South,
P.O. Box 300,
Raritan, NJ 08869.
NDA 020347.................... HYTRIN (terazosin Abbott Laboratories
HCl) Capsule; Pharmaceutical
Oral, EQ 1 mg Products Division,
Base; EQ 2 mg Dept. 491 AP6B 1,
Base; EQ 5 mg Abbott Park, IL
Base; EQ 10 mg 60064.
Base.
NDA 020560.................... FOSAMAX Merck and Co. Inc.,
(alendronate 126 East Lincoln
sodium) Tablet; Ave., RY 33 212,
Oral, EQ 5 mg P.O. Box 2000,
Base; EQ 10 mg Rahway, NJ 07065-
Base; EQ 35 mg 0900.
Base; EQ 40 mg
Base.
NDA 020813.................... KLONOPIN Hoffmann-La Roche
(clonazepam) Inc., 340
Tablet, Orally Kingsland St.,
Disintegrating Nutley, NJ 07110.
Tablet (ODT);
Oral, 0.125 mg,
0.25 mg, 0.5 mg, 1
mg, 2 mg.
NDA 021046.................... CELEXA (citalopram Forest Laboratories
hydrobromide) Inc., Harborside
Solution; Oral, EQ Financial Center,
10 mg Base/5 mL. Plaza V, Suite
1900, Jersey City,
NJ 07311.
NDA 022246.................... METOZOLV ODT Salix
(metoclopramide Pharmaceuticals
HCl) Tablet, ODT; Inc., 8510
Oral, EQ 10 mg Colonnade Center
Base. Dr., Raleigh, NC
27615.
NDA 050533.................... VIBRA-TABS Pfizer Laboratories
(doxycycline Inc., 235 East
hyclate) Tablet; 42nd St., New
Oral, EQ 100 mg York, NY 10017.
Base.
------------------------------------------------------------------------
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 listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. 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: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19272 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P
