Determination That BENEMID (Probenecid) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 81780-81782 [2016-27855]
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81780
Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
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Submit written/paper submissions as
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2016–D–3750 for ‘‘Revised
Recommendations for Determining
Eligibility of Donors of Human Cells,
Tissues, and Cellular and Tissue-Based
Products Who Have Received HumanDerived Clotting Factor Concentrates;
Guidance for Industry.’’ Received
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regulatoryinformation/dockets/
default.htm.
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for electronic access to the guidance
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FOR FURTHER INFORMATION CONTACT:
Melissa Segal, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Revised
Recommendations for Determining
Eligibility of Donors of Human Cells,
Tissues, and Cellular and Tissue-Based
Products Who Have Received HumanDerived Clotting Factor Concentrates;
Guidance for Industry.’’ The guidance
document provides establishments that
make DE determinations for donors of
HCT/Ps with information on infectious
disease risks related to receipt of
HDCFCs. The guidance explains that
FDA no longer considers FDA licensed
HDCFCs as a risk factor for HIV, HBV,
or HCV. As such, receipt of FDA
licensed HDCFCs, or sex with a person
who has received FDA licensed
HDCFCs, should not be considered a
risk factor when determining eligibility
of a donor of HCT/Ps. The
recommendations in the guidance
supersede the recommendations
contained in section IV.E.3. of the
guidance entitled ‘‘Eligibility
Determination for Donors of Human
Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps); Guidance for
Industry’’ dated August 2007.
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This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
FDA is issuing this guidance for
immediate implementation in
accordance with 21 CFR 10.115(g)(2)
without initially seeking prior comment
because the Agency has determined that
prior public participation is not
appropriate. This guidance recommends
a less burdensome policy that is
consistent with the public health. The
guidance represents the current thinking
of FDA on ‘‘Revised Recommendations
for Determining Eligibility of Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products Who Have
Received Human-Derived Clotting
Factor Concentrates.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 1271.47 have been approved
under OMB control number 0910–0543.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27768 Filed 11–17–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3680]
Determination That BENEMID
(Probenecid) 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 or Agency) has
SUMMARY:
E:\FR\FM\18NON1.SGM
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81781
Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
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:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6207, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
NDA 007898 .......
NDA 008048 .......
BENEMID .........................
XYLOCAINE .....................
Probenecid .......................
Lidocaine ..........................
500 milligrams (mg) ..............
5% .........................................
Tablet; Oral ......................
Ointment; Topical .............
NDA 011111 .......
VISTARIL .........................
FLUOROURACIL .............
Hydroxyzine Hydrochloride (HCl).
Fluorouracil ......................
25 mg/milliliter (mL); 50 mg/
mL.
500 mg/10 mL (50 mg/mL) ...
Injectable; Injection ..........
NDA 012209 .......
NDA 013220 .......
NDA 017534 .......
PERIACTIN ......................
FIORINAL .........................
Syrup; Oral .......................
Tablet; Oral ......................
DITROPAN .......................
Cyproheptadine HCl .........
Aspirin; Butalbital; Caffeine.
Oxybutynin Chloride .........
2 mg/5 mL .............................
325 mg; 50 mg; 40 mg .........
NDA 017577 .......
5 mg ......................................
Tablet; Oral ......................
NDA 017781 .......
DIPROSONE ....................
DITROPAN .......................
Betamethasone
Dipropionate.
Oxybutynin Chloride .........
Equivalent to (EQ) 0.05%
Base.
5 mg/5 mL .............................
Lotion; Topical ..................
NDA 018211 .......
Syrup; Oral .......................
NDA 018586 .......
TOPICORT .......................
Desoximetasone ..............
0.05% ....................................
Gel; Topical ......................
NDA 018631 .......
TRENTAL .........................
Pentoxifylline ....................
400 mg ..................................
NDA 019155 .......
NDA 019323 .......
LAC–HYDRIN ..................
TEMOVATE .....................
Ammonium Lactate ..........
Clobetasol Propionate ......
EQ 12% Base .......................
0.05% ....................................
Extended-Release Tablet;
Oral.
Lotion; Topical ..................
Ointment; Topical .............
NDA 019778 .......
PRINZIDE ........................
Hydrochlorothiazide;
Lisinopril.
12.5 mg/10 mg; 12.5mg/
20mg.
Tablet; Oral ......................
NDA 019842 .......
MOTRIN ...........................
Ibuprofen ..........................
100 mg/5 mL .........................
Suspension; Oral .............
NDA 019915 .......
NDA 020343 .......
MONOPRIL ......................
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER.
Fosinopril Sodium ............
Milrinone Lactate ..............
LAC–HYDRIN ..................
Ammonium Lactate ..........
10 mg; 20 mg; 40 mg ...........
EQ 10 mg Base/100 mL; EQ
15 mg Base/100 mL; EQ
20 mg Base/100 mL; EQ
40 mg Base/200 mL.
EQ 12% Base .......................
Tablet; Oral ......................
Injectable; Injection ..........
NDA 020508 .......
NDA 020635 .......
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Application No.
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER.
Levofloxacin .....................
Injectable; Injection ..........
NDA 020863 .......
PLETAL ............................
Cilostazol ..........................
EQ 250 mg/50 mL (EQ 5 mg/
mL); EQ 500 mg/100 mL
(EQ 5 mg/mL); EQ 750
mg/150 mL (EQ 5 mg/mL).
50 mg; 100 mg ......................
Tablet; Oral ......................
NDA 20950 .........
DUONEB ..........................
EQ 0.083% Base; 0.017% ....
Solution; Inhalation ..........
NDA 21460 .........
METAGLIP .......................
Albuterol Sulfate;
Ipratropium Bromide.
Glipizide; Metformin HCl ..
Otsuka Pharmaceutical
Co., Ltd.
Mylan Specialty, L.P.
Tablet; Oral ......................
Bristol-Myers Squibb Co.
NDA 021759 .......
ELOXATIN .......................
Oxaliplatin ........................
2.5 mg/250 mg; 2.5 mg/500
mg; 5 mg/500 mg.
200 mg/40 mL (5 mg/mL) .....
Sanofi-Aventis U.S. LLC.
NDA 050442 .......
VIBRAMYCIN ...................
Doxycycline Hyclate .........
Injectable; Intravenous
(Infusion).
Injectable; Injection ..........
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EQ 100 mg Base/Vial; EQ
200 mg Base/Vial.
Fmt 4703
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Injectable; Injection ..........
Cream; Topical .................
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Applicant
Merck and Co., Inc.
AstraZeneca Pharmaceuticals LP.
Pfizer Inc.
Spectrum Pharmaceuticals, Inc.
Merck and Co., Inc.
Allergan Sales, LLC.
Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Schering Corp.
Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Taro Pharmaceuticals
U.S.A., Inc.
U.S. Pharmaceutical Holdings II, LLC.
Ranbaxy Laboratories Inc.
Fougera Pharmaceuticals
Inc.
Merck Sharp & Dohme
Corp., Subsidiary of
Merck & Co., Inc.
McNeil Consumer
Healthcare Division of
McNEIL–PPC, Inc.
Bristol-Myers Squibb Co.
Sanofi-Aventis U.S. LLC.
Ranbaxy Laboratories,
Inc.
Janssen Pharmaceuticals,
Inc.
Pfizer Inc.
81782
Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
NDA 050624 .......
ROCEPHIN W/DEXTROSE IN PLASTIC
CONTAINER.
OMNICEF .........................
OMNICEF .........................
V–CILLIN K ......................
Ceftriaxone Sodium .........
Injectable; Injection ..........
Hoffmann-La Roche, Inc.
Capsule; Oral ...................
For Suspension; Oral .......
Tablet; Oral ......................
AbbVie Inc.
AbbVie Inc.
Eli Lilly and Company.
Gentamicin Sulfate ...........
Cyproheptadine HCl .........
EQ 10 mg Base/mL; EQ 20
mg Base/mL; EQ 40 mg
Base/mL.
300 mg ..................................
125 mg/5 mL; 250 mg/5 mL
EQ 125 mg Base; EQ 250
mg Base; EQ 500 mg
Base.
EQ 0.1% Base ......................
2 mg/5mL ..............................
Ointment; Topical .............
Syrup; Oral .......................
Schering-Plough Corp.
Actavis Mid Atlantic LLC.
Benztropine Mesylate ......
0.5 mg ...................................
Tablet; Oral ......................
Lannett Holdings, Inc.
Benztropine Mesylate ......
1 mg ......................................
Tablet; Oral ......................
Lannett Holdings, Inc.
Benztropine Mesylate ......
2 mg ......................................
Tablet; Oral ......................
Lannett Holdings, Inc.
NDA 050739 .......
NDA 050749 .......
ANDA 060003 .....
ANDA 060463 .....
ANDA 086833 .....
ANDA 088877 .....
ANDA 088894 .....
ANDA 088895 .....
GARAMYCIN ...................
CYPROHEPTADINE HYDROCHLORIDE.
BENZTROPINE
MESYLATE.
BENZTROPINE
MESYLATE.
BENZTROPINE
MESYLATE.
Cefdinir .............................
Cefdinir .............................
Penicillin V Potassium .....
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: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27855 Filed 11–17–16; 8:45 am]
mstockstill on DSK3G9T082PROD with NOTICES
BILLING CODE 4164–01–P
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Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2015–M–3249, FDA–
2015–M–3251, FDA–2015–M–3253, FDA–
2015–M–4130, FDA 2015–M–3254, FDA–
2016–M–2210, FDA–2014–M–0740, FDA–
2016–M–1072, FDA–2014–M–2304, FDA–
2014–M–2305, FDA–2015–M–2100, FDA–
2015–M–3255, FDA–2015–M–4981]
Medical Devices Regulated by the
Center for Biologics Evaluation and
Research; Availability of Safety and
Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved by the
Center for Biologics Evaluation and
Research (CBER). This list is intended to
inform the public of the availability of
safety and effectiveness summaries of
approved PMAs through the Internet
and the Agency’s Division of Dockets
Management.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
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Applicant
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public submit the comment as a written/
paper submission and in the manner
detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2015–M–3249, FDA–2015–M–3251,
FDA–2015–M–3253, FDA–2015–M–
4130, 2015–M–3254, FDA–2016–M–
2210, FDA–2014–M–0740, FDA–2016–
M–1072, FDA–2014–M–2304, FDA–
2014–M–2305, FDA–2015–M–2100,
FDA–2015–M–3255, FDA–2015–M–
4981 for ‘‘Medical Devices Regulated by
the Center for Biologics Evaluation and
Research; Availability of Safety and
Effectiveness Summaries for Premarket
Approval Applications.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
E:\FR\FM\18NON1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81780-81782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27855]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3680]
Determination That BENEMID (Probenecid) 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 or Agency) has
[[Page 81781]]
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: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363,
Stacy.Kane@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.
----------------------------------------------------------------------------------------------------------------
Active Dosage form/
Application No. Drug name ingredient(s) Strength(s) route Applicant
----------------------------------------------------------------------------------------------------------------
NDA 007898.......... BENEMID.......... Probenecid....... 500 milligrams Tablet; Oral.... Merck and Co.,
(mg). Inc.
NDA 008048.......... XYLOCAINE........ Lidocaine........ 5%.............. Ointment; AstraZeneca
Topical. Pharmaceuticals
LP.
NDA 011111.......... VISTARIL......... Hydroxyzine 25 mg/milliliter Injectable; Pfizer Inc.
Hydrochloride (mL); 50 mg/mL. Injection.
(HCl).
NDA 012209.......... FLUOROURACIL..... Fluorouracil..... 500 mg/10 mL (50 Injectable; Spectrum
mg/mL). Injection. Pharmaceuticals
, Inc.
NDA 013220.......... PERIACTIN........ Cyproheptadine 2 mg/5 mL....... Syrup; Oral..... Merck and Co.,
HCl. Inc.
NDA 017534.......... FIORINAL......... Aspirin; 325 mg; 50 mg; Tablet; Oral.... Allergan Sales,
Butalbital; 40 mg. LLC.
Caffeine.
NDA 017577.......... DITROPAN......... Oxybutynin 5 mg............ Tablet; Oral.... Ortho-McNeil-
Chloride. Janssen
Pharmaceuticals
, Inc.
NDA 017781.......... DIPROSONE........ Betamethasone Equivalent to Lotion; Topical. Schering Corp.
Dipropionate. (EQ) 0.05% Base.
NDA 018211.......... DITROPAN......... Oxybutynin 5 mg/5 mL....... Syrup; Oral..... Ortho-McNeil-
Chloride. Janssen
Pharmaceuticals
, Inc.
NDA 018586.......... TOPICORT......... Desoximetasone... 0.05%........... Gel; Topical.... Taro
Pharmaceuticals
U.S.A., Inc.
NDA 018631.......... TRENTAL.......... Pentoxifylline... 400 mg.......... Extended-Release U.S.
Tablet; Oral. Pharmaceutical
Holdings II,
LLC.
NDA 019155.......... LAC-HYDRIN....... Ammonium Lactate. EQ 12% Base..... Lotion; Topical. Ranbaxy
Laboratories
Inc.
NDA 019323.......... TEMOVATE......... Clobetasol 0.05%........... Ointment; Fougera
Propionate. Topical. Pharmaceuticals
Inc.
NDA 019778.......... PRINZIDE......... Hydrochlorothiazi 12.5 mg/10 mg; Tablet; Oral.... Merck Sharp &
de; Lisinopril. 12.5mg/20mg. Dohme Corp.,
Subsidiary of
Merck & Co.,
Inc.
NDA 019842.......... MOTRIN........... Ibuprofen........ 100 mg/5 mL..... Suspension; Oral McNeil Consumer
Healthcare
Division of
McNEIL-PPC,
Inc.
NDA 019915.......... MONOPRIL......... Fosinopril Sodium 10 mg; 20 mg; 40 Tablet; Oral.... Bristol-Myers
mg. Squibb Co.
NDA 020343.......... PRIMACOR IN Milrinone Lactate EQ 10 mg Base/ Injectable; Sanofi-Aventis
DEXTROSE 5% IN 100 mL; EQ 15 Injection. U.S. LLC.
PLASTIC mg Base/100 mL;
CONTAINER. EQ 20 mg Base/
100 mL; EQ 40
mg Base/200 mL.
NDA 020508.......... LAC-HYDRIN....... Ammonium Lactate. EQ 12% Base..... Cream; Topical.. Ranbaxy
Laboratories,
Inc.
NDA 020635.......... LEVAQUIN IN Levofloxacin..... EQ 250 mg/50 mL Injectable; Janssen
DEXTROSE 5% IN (EQ 5 mg/mL); Injection. Pharmaceuticals
PLASTIC EQ 500 mg/100 , Inc.
CONTAINER. mL (EQ 5 mg/
mL); EQ 750 mg/
150 mL (EQ 5 mg/
mL).
NDA 020863.......... PLETAL........... Cilostazol....... 50 mg; 100 mg... Tablet; Oral.... Otsuka
Pharmaceutical
Co., Ltd.
NDA 20950........... DUONEB........... Albuterol EQ 0.083% Base; Solution; Mylan Specialty,
Sulfate; 0.017%. Inhalation. L.P.
Ipratropium
Bromide.
NDA 21460........... METAGLIP......... Glipizide; 2.5 mg/250 mg; Tablet; Oral.... Bristol-Myers
Metformin HCl. 2.5 mg/500 mg; Squibb Co.
5 mg/500 mg.
NDA 021759.......... ELOXATIN......... Oxaliplatin...... 200 mg/40 mL (5 Injectable; Sanofi-Aventis
mg/mL). Intravenous U.S. LLC.
(Infusion).
NDA 050442.......... VIBRAMYCIN....... Doxycycline EQ 100 mg Base/ Injectable; Pfizer Inc.
Hyclate. Vial; EQ 200 mg Injection.
Base/Vial.
[[Page 81782]]
NDA 050624.......... ROCEPHIN W/ Ceftriaxone EQ 10 mg Base/ Injectable; Hoffmann-La
DEXTROSE IN Sodium. mL; EQ 20 mg Injection. Roche, Inc.
PLASTIC Base/mL; EQ 40
CONTAINER. mg Base/mL.
NDA 050739.......... OMNICEF.......... Cefdinir......... 300 mg.......... Capsule; Oral... AbbVie Inc.
NDA 050749.......... OMNICEF.......... Cefdinir......... 125 mg/5 mL; 250 For Suspension; AbbVie Inc.
mg/5 mL. Oral.
ANDA 060003......... V-CILLIN K....... Penicillin V EQ 125 mg Base; Tablet; Oral.... Eli Lilly and
Potassium. EQ 250 mg Base; Company.
EQ 500 mg Base.
ANDA 060463......... GARAMYCIN........ Gentamicin EQ 0.1% Base.... Ointment; Schering-Plough
Sulfate. Topical. Corp.
ANDA 086833......... CYPROHEPTADINE Cyproheptadine 2 mg/5mL........ Syrup; Oral..... Actavis Mid
HYDROCHLORIDE. HCl. Atlantic LLC.
ANDA 088877......... BENZTROPINE Benztropine 0.5 mg.......... Tablet; Oral.... Lannett
MESYLATE. Mesylate. Holdings, Inc.
ANDA 088894......... BENZTROPINE Benztropine 1 mg............ Tablet; Oral.... Lannett
MESYLATE. Mesylate. Holdings, Inc.
ANDA 088895......... BENZTROPINE Benztropine 2 mg............ Tablet; Oral.... Lannett
MESYLATE. Mesylate. Holdings, Inc.
----------------------------------------------------------------------------------------------------------------
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: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27855 Filed 11-17-16; 8:45 am]
BILLING CODE 4164-01-P
