Determination That DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 19735-19737 [2017-08582]
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Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
performing the evaluation, procedure
and follow-up necessary to ensure
optimal patient outcomes. In accordance
with this criteria, we consider coverage
for CAS reasonable and necessary
(section 1862(A)(1)(a) of the Social
Security Act). Form Number: CMS–
10199 (OMB control number: 0938–
1011); Frequency: Yearly; Affected
Public: Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 1,370; Total Annual
Responses: 4,110; Total Annual Hours:
28,998. (For policy questions regarding
this collection contact Sarah Fulton at
410–786–2749.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Conditions of
Coverage for Organ Procurement
Organizations and Supporting
Regulations; Use: Section 1138(b) of the
Social Security Act, as added by section
9318 of the Omnibus Budget
Reconciliation Act of 1986 (Pub. L. 99–
509), sets forth the statutory
qualifications and requirements that
organ procurement organizations
(OPOs) must meet in order for the costs
of their services in procuring organs for
transplant centers to be reimbursable
under the Medicare and Medicaid
programs. An OPO must be certified and
designated by the Secretary as an OPO
and must meet performance-related
standards prescribed by the Secretary.
The corresponding regulations are
found at 42 CFR part 486 (Conditions
for Coverage of Specialized Services
Furnished by Suppliers) under subpart
G (Requirements for Certification and
Designation and Conditions for
Coverage: Organ Procurement
Organizations).
Since each OPO has a monopoly on
organ procurement within its designated
service area (DSA), we must hold OPOs
to high standards. Collection of this
information is necessary for us to assess
the effectiveness of each OPO and
determine whether it should continue to
be certified as an OPO and designated
for a particular donation service area by
the Secretary or replaced by an OPO
that can more effectively procure organs
within that DSA. Form Number: CMS–
R–13 (OMB control number: 0938–
0688); Frequency: Occasionally;
Affected Public: Not-for-profit
institutions; Number of Respondents:
58; Total Annual Responses: 58; Total
Annual Hours: 13,546. (For policy
questions regarding this collection
contact Diane Corning at 410–786–
8486.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
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Information Collection: Ambulatory
Surgical Center Conditions for Coverage;
Use: The Ambulatory Surgical Center
(ASC) Conditions for Coverage (CfCs)
focus on a patient-centered, outcomeoriented, and transparent processes that
promote quality patient care. The CfCs
are designed to ensure that each facility
has properly trained staff to provide the
appropriate type and level of care for
that facility and provide a safe physical
environment for patients. The CfCs are
used by Federal or state surveyors as a
basis for determining whether an ASC
qualifies for approval or re-approval
under Medicare. We, along with the
healthcare industry, believe that the
availability to the facility of the type of
records and general content of records,
which this regulation specifies, is
standard medical practice and is
necessary in order to ensure the wellbeing and safety of patients and
professional treatment accountability.
Form Number: CMS–10279 (OMB
control number: 0938–1071); Frequency:
Annual; Affected Public: Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
5,500; Total Annual Responses: 5,500;
Total Annual Hours: 209,000. (For
policy questions regarding this
collection contact Jacqueline Leach at
410–786–4282.)
Dated: April 26, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–08738 Filed 4–27–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1551]
Determination That DEMEROL
(Meperidine Hydrochloride) Injectable
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
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
SUMMARY:
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
19735
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements. Through this notice, FDA
is hoping to stimulate the economy and
increase the regulatory certainty with
respect to generic versions of these drug
products by confirming that generic
versions of the subject drug products
may continue to be marketed.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, 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 § 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
E:\FR\FM\28APN1.SGM
28APN1
19736
Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
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 name
Active ingredient(s)
Strength(s)
Dosage form/route
Applicant
NDA 005010 .........
DEMEROL .......................
Meperidine Hydrochloride
Syrup; Oral .......................
NDA 006035 .........
NDA 007337 .........
METHERGINE .................
PERCODAN and
PERCODAN–DEMI.
U.S. Pharmaceutical
Holdings II, LLC.
Edison Therapeutics LLC.
Endo Pharmaceuticals
Inc.
NDA 008720 .........
LEVO–DROMORAN ........
Methylergonovine Maleate
Aspirin, Oxycodone Hydrochloride, Oxycodone
Terephthalate.
Levorphanol Tartrate .......
50 milligrams (mg)/5 milliliter
(mL).
0.2 mg ...................................
325 mg, 4.5 mg, 0.38 mg;
and 325 mg, 2.25 mg, 0.19
mg.
2 mg ......................................
Tablet; Oral ......................
NDA 008848 .........
2.5 mg and 5 mg ..................
Tablet; Oral ......................
NDA 009470 .........
NDA 010485 .........
PAMINE and PAMINE
FORTE.
XYLOCAINE VISCOUS ...
ATARAX ...........................
NDA 010742 .........
COMPAZINE ....................
NDA 012111 .........
Tablet; Oral ......................
Tablet; Oral ......................
Solution; Oral ...................
Syrup; Oral .......................
Equivalent to (EQ) 5 mg
Base/mL.
0.5%; 1% ..............................
Injectable; Injection ..........
GlaxoSmithKline.
PLEGINE .........................
Phendimetrazine Tartrate
35 mg ....................................
Solution/Drops; Ophthalmic.
Tablet; Oral ......................
Alcon Laboratories Inc.
NDA 012248 .........
NDA 012365 .........
SOMA COMPOUND ........
Aspirin; Carisoprodol .......
325 mg; 200 mg ...................
Tablet; Oral ......................
NDA 012366 .........
SOMA COMPOUND W/
CODEINE.
VIVACTIL .........................
Aspirin; Carisoprodol; Codeine Phosphate.
Protriptyline Hydrochloride
325 mg; 200 mg; 16 mg .......
Tablet; Oral ......................
NDA 016012 .........
5 mg; 10 mg .........................
Tablet; Oral ......................
NDA 017352 .........
FASTIN ............................
Capsule; Oral ...................
IMODIUM .........................
Phentermine Hydrochloride.
Loperamide Hydrochloride
30 mg ....................................
NDA 017690 .........
2 mg ......................................
Capsule; Oral ...................
NDA 017694 .........
NDA 017741 .........
IMODIUM .........................
FLORONE ........................
Loperamide Hydrochloride
Diflorasone Diacetate ......
2 mg ......................................
0.05% ....................................
Capsule; Oral ...................
Cream; Topical ................
NDA 017802 .........
LO/OVRAL–28 .................
Tablet; Oral-28 .................
2 mg/mL ................................
1 mg/mL; 2 mg/mL ...............
Injectable; Injection ..........
Injectable; Injection ..........
Johnson & Johnson Consumer Inc.
Ditto.
Pharmacia and Upjohn
Co.
Wyeth Pharmaceuticals
Inc.
Delcor Asset Corporation.
Ditto.
NDA 018342 .........
STADOL ...........................
STADOL PRESERVATIVE FREE.
WELLCOVORIN ..............
Ethinyl Estradiol;
Norgestrel.
Butorphanol Tartrate ........
Butorphanol Tartrate ........
0.03 mg; 0.3 mg ...................
NDA 017857 .........
NDA 017857 .........
GlaxoSmithKline.
FLAGYL I.V. .....................
EQ 5 mg Base; EQ 25 mg
Base.
EQ 500 mg Base/Vial ...........
Tablet; Oral ......................
NDA 018353 .........
Injectable; Injection ..........
NDA 018733 .........
TALWIN NX .....................
EQ 0.5 mg Base; EQ 50 mg
Base.
Tablet; Oral ......................
G.D. Searle LLC, a subsidiary of Pfizer Inc.
Sanofi-Aventis U.S. LLC.
NDA 019488 .........
NDA 019578 .........
CARDENE .......................
MEFLOQUINE HYDROCHLORIDE.
20 mg; 30 mg .......................
250 mg ..................................
Capsule; Oral ...................
Tablet; Oral ......................
NDA 019591 .........
NDA 019735 .........
LARIAM ............................
FLOXIN ............................
Mefloquine Hydrochloride
Ofloxacin ..........................
250 mg ..................................
200 mg; 300 mg; 400 mg .....
Tablet; Oral ......................
Tablet; Oral ......................
NDA 019890 .........
NDA 020142 .........
STADOL ...........................
CATAFLAM ......................
Butorphanol Tartrate ........
Diclofenac Potassium ......
1 mg/Spray ...........................
50 mg ....................................
Spray, Metered; Nasal .....
Tablet; Oral ......................
NDA 020254 .........
VOLTAREN–XR ...............
Diclofenac Sodium ...........
100 mg ..................................
NDA 020312 .........
NDA 020346 .........
UNIVASC .........................
ZYRTEC ...........................
Moexipril Hydrochloride ...
Cetirizine Hydrochloride ...
7.5 mg; 15 mg ......................
5 mg/5 mL .............................
Extended-Release Tablet;
Oral.
Tablet; Oral ......................
Syrup; Oral .......................
NDA 020584 .........
LODINE XL ......................
Etodolac ...........................
400 mg; 500 mg; 600 mg .....
NDA 020625 .........
ALLEGRA ........................
UNIRETIC ........................
NDA 021066 .........
ZADITOR .........................
Fexofenadine Hydrochloride.
Hydro chlorothiazide;
Moexipril Hydrochloride.
Ketotifen Fumarate ..........
60 mg ....................................
NDA 020729 .........
asabaliauskas on DSK3SPTVN1PROD with NOTICES
2% .........................................
10 mg/5 mL ...........................
MYDRIACYL ....................
Methscopolamine Bromide.
Lidocaine Hydrochloride ..
Hydroxyzine Hydrochloride.
Prochlorperazine
Edisylate.
Tropicamide .....................
Valeant Pharmaceuticals
North America LLC.
Fougera Pharmaceuticals
Inc.
Fresenius Kabi USA, LLC.
Pfizer Inc.
NDA 021224 .........
RAZADYNE .....................
NDA 021378 .........
COMBUNOX ....................
NDA 021473 .........
CIPRO XR .......................
NDA 021606 .........
NDA 021729 .........
ZEMPLAR ........................
ABILIFY ............................
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Leucovorin Calcium .........
Metronidazole Hydrochloride.
Naloxone Hydrochloride;
Pentazocine Hydrochloride.
Nicardipine Hydrochloride
Mefloquine Hydrochloride
Galantamine
Hydrobromide.
Ibuprofen; Oxycodone Hydrochloride.
Ciprofloxacin;
Ciprofloxacin Hydrochloride.
Paricalcitol ........................
Aripiprazole ......................
PO 00000
Frm 00085
Wyeth Ayerst Laboratories.
Meda Pharmaceuticals
Inc.
Ditto.
Teva Women’s Health,
Inc.
GlaxoSmithKline.
Chiesi USA, Inc.
U.S. Army Walter Reed
Army Institute Research.
Hoffmann-La Roche Inc.
Janssen Pharmaceuticals,
Inc.
Bristol-Myers Squibb Co.
Novartis Pharmaceuticals
Corp.
Ditto.
Extended-Release Tablet;
Oral.
Capsule; Oral ...................
UCB, Inc.
Johnson & Johnson Consumer Inc.
Wyeth Pharmaceuticals
Inc.
Sanofi-Aventis U.S. LLC.
Tablet; Oral ......................
UCB, Inc.
4 mg/mL ................................
Solution/Drops; Ophthalmic.
Solution; Oral ...................
400 mg; 5 mg .......................
Tablet; Oral ......................
Alcon Pharmaceuticals,
Ltd.
Janssen Pharmaceuticals,
Inc.
Forest Laboratories, Inc.
212.6 mg; EQ 287.5 mg
Base; 425.2 mg; EQ 574.9
mg Base.
4 micrograms (mcg) ..............
10 mg and 15 mg .................
Extended-Release Tablet;
Oral.
Bayer HealthCare Pharmaceuticals, Inc.
Capsule; Oral ...................
Tablet, Orally Disintegrating; Oral.
AbbVie Inc.
Otsuka Pharmaceutical
Co., Ltd.
12.5 mg/7.5 mg; 12.5 mg/15
mg; 25 mg/15 mg.
EQ 0.025% Base ..................
Fmt 4703
Sfmt 4703
E:\FR\FM\28APN1.SGM
28APN1
Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
19737
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
NDA 050072 .........
PENBRITIN–S .................
Ampicillin Sodium ............
Wyeth Ayerst Laboratories.
POLYCILLIN–N ................
Ampicillin Sodium ............
Injectable; Injection ..........
Bristol Laboratories Inc.
NDA 050674 .........
VANTIN ............................
Cefpodoxime Proxetil .......
Tablet; Oral ......................
ANDA 064170 ......
CEFAZOLIN SODIUM .....
Cefazolin Sodium .............
Injectable; Injection ..........
Pharmacia and Upjohn
Co.
Fresenius Kabi USA, LLC.
ANDA 075406 ......
OGESTREL 0.5/50–21 ....
Tablet; Oral-21 .................
Watson Laboratories, Inc.
ANDA 085106 ......
PERCOCET .....................
325 mg; 5 mg .......................
Tablet; Oral ......................
Vintage Pharmaceuticals
LLC.
ANDA 089351 ......
ROXICET .........................
325 mg/5 mL; 5 mg/5 mL .....
Solution; Oral ...................
ANDA 089456 ......
ANDA 089457 ......
PERPHENAZINE .............
PERPHENAZINE .............
Ethinyl Estradiol;
Norgestrel.
Acetaminophen;
Oxycodone Hydrochloride.
Acetaminophen;
Oxycodone Hydrochloride.
Perphenazine ...................
Perphenazine ...................
EQ 125 mg Base/Vial; EQ
250 mg Base/Vial; EQ 500
mg Base/Vial; EQ 1 gram
(g) Base/Vial; EQ 2 g
Base/Vial; EQ 4 g Base/
Vial.
EQ 125 mg Base/Vial; EQ
250 mg Base/Vial; EQ 500
mg Base/Vial; EQ 1 g
Base/Vial; EQ 2 g Base/
Vial.
EQ 100 mg Base; EQ 200
mg Base.
EQ 10 g Base/Vial; EQ 20 g
Base/Vial.
0.05 mg; 0.5 mg ...................
Injectable; Injection ..........
NDA 050309 .........
8 mg ......................................
16 mg ....................................
Tablet; Oral ......................
Tablet; Oral ......................
ANDA 089707 ......
ANDA 089708 ......
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Application No.
PERPHENAZINE .............
PERPHENAZINE .............
Perphenazine ...................
Perphenazine ...................
2 mg ......................................
4 mg ......................................
Tablet; Oral ......................
Tablet; Oral ......................
West-Ward Pharmaceuticals International
Ltd.
ANI Pharmaceuticals, Inc.
Teva Pharmaceuticals
USA.
Ditto.
Do.
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.
This is not a significant regulatory
action subject to Executive Order 12866,
and does not impose any additional
burden on regulated entities.
Dated: April 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08582 Filed 4–27–17; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1114]
Pharmaceutical Distribution Supply
Chain Pilot Projects; Reopening of
Comment Period; Request for
Information
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of comment
period; request for information.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for the Request for
Information that appeared in the
Federal Register of April 15, 2016. In
the Request for Information, FDA
requested comments regarding issues
related to utilizing the product identifier
for product tracing, improving the
technical capabilities of the supply
chain, and identifying system attributes
that are necessary to implement the
requirements established under the
Drug Supply Chain Security Act
(DSCSA). The information gathered
from additional public comments will
further inform the design and
development of the pilot project(s) that
FDA establishes under the DSCSA. FDA
is reopening the comment period to
receive updated comments and any new
information.
DATES: FDA is reopening the comment
period on the Request for Information
published April 15, 2016 (81 FR 22279).
Submit either electronic or written
SUMMARY:
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
Applicant
comments by April 30, 2018. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 30,
2018. The https://www.regulations.gov/
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 30, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES: You may submit comments
as follows:
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 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/.
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19735-19737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08582]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1551]
Determination That DEMEROL (Meperidine Hydrochloride) Injectable
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
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. Through this notice, FDA is hoping to
stimulate the economy and increase the regulatory certainty with
respect to generic versions of these drug products by confirming that
generic versions of the subject drug products may continue to be
marketed.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, 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
[[Page 19736]]
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 005010............ DEMEROL......... Meperidine 50 milligrams Syrup; Oral..... U.S.
Hydrochloride. (mg)/5 Pharmaceutical
milliliter (mL). Holdings II,
LLC.
NDA 006035............ METHERGINE...... Methylergonovine 0.2 mg.......... Tablet; Oral.... Edison
Maleate. Therapeutics
LLC.
NDA 007337............ PERCODAN and Aspirin, 325 mg, 4.5 mg, Tablet; Oral.... Endo
PERCODAN-DEMI. Oxycodone 0.38 mg; and Pharmaceuticals
Hydrochloride, 325 mg, 2.25 Inc.
Oxycodone mg, 0.19 mg.
Terephthalate.
NDA 008720............ LEVO-DROMORAN... Levorphanol 2 mg............ Tablet; Oral.... Valeant
Tartrate. Pharmaceuticals
North America
LLC.
NDA 008848............ PAMINE and Methscopolamine 2.5 mg and 5 mg. Tablet; Oral.... Fougera
PAMINE FORTE. Bromide. Pharmaceuticals
Inc.
NDA 009470............ XYLOCAINE Lidocaine 2%.............. Solution; Oral.. Fresenius Kabi
VISCOUS. Hydrochloride. USA, LLC.
NDA 010485............ ATARAX.......... Hydroxyzine 10 mg/5 mL...... Syrup; Oral..... Pfizer Inc.
Hydrochloride.
NDA 010742............ COMPAZINE....... Prochlorperazine Equivalent to Injectable; GlaxoSmithKline.
Edisylate. (EQ) 5 mg Base/ Injection.
mL.
NDA 012111............ MYDRIACYL....... Tropicamide..... 0.5%; 1%........ Solution/Drops; Alcon
Ophthalmic. Laboratories
Inc.
NDA 012248............ PLEGINE......... Phendimetrazine 35 mg........... Tablet; Oral.... Wyeth Ayerst
Tartrate. Laboratories.
NDA 012365............ SOMA COMPOUND... Aspirin; 325 mg; 200 mg.. Tablet; Oral.... Meda
Carisoprodol. Pharmaceuticals
Inc.
NDA 012366............ SOMA COMPOUND W/ Aspirin; 325 mg; 200 mg; Tablet; Oral.... Ditto.
CODEINE. Carisoprodol; 16 mg.
Codeine
Phosphate.
NDA 016012............ VIVACTIL........ Protriptyline 5 mg; 10 mg..... Tablet; Oral.... Teva Women's
Hydrochloride. Health, Inc.
NDA 017352............ FASTIN.......... Phentermine 30 mg........... Capsule; Oral... GlaxoSmithKline.
Hydrochloride.
NDA 017690............ IMODIUM......... Loperamide 2 mg............ Capsule; Oral... Johnson &
Hydrochloride. Johnson
Consumer Inc.
NDA 017694............ IMODIUM......... Loperamide 2 mg............ Capsule; Oral... Ditto.
Hydrochloride.
NDA 017741............ FLORONE......... Diflorasone 0.05%........... Cream; Topical.. Pharmacia and
Diacetate. Upjohn Co.
NDA 017802............ LO/OVRAL-28..... Ethinyl 0.03 mg; 0.3 mg. Tablet; Oral-28. Wyeth
Estradiol; Pharmaceuticals
Norgestrel. Inc.
NDA 017857............ STADOL.......... Butorphanol 2 mg/mL......... Injectable; Delcor Asset
Tartrate. Injection. Corporation.
NDA 017857............ STADOL Butorphanol 1 mg/mL; 2 mg/mL Injectable; Ditto.
PRESERVATIVE Tartrate. Injection.
FREE.
NDA 018342............ WELLCOVORIN..... Leucovorin EQ 5 mg Base; EQ Tablet; Oral.... GlaxoSmithKline.
Calcium. 25 mg Base.
NDA 018353............ FLAGYL I.V...... Metronidazole EQ 500 mg Base/ Injectable; G.D. Searle LLC,
Hydrochloride. Vial. Injection. a subsidiary of
Pfizer Inc.
NDA 018733............ TALWIN NX....... Naloxone EQ 0.5 mg Base; Tablet; Oral.... Sanofi-Aventis
Hydrochloride; EQ 50 mg Base. U.S. LLC.
Pentazocine
Hydrochloride.
NDA 019488............ CARDENE......... Nicardipine 20 mg; 30 mg.... Capsule; Oral... Chiesi USA, Inc.
Hydrochloride.
NDA 019578............ MEFLOQUINE Mefloquine 250 mg.......... Tablet; Oral.... U.S. Army Walter
HYDROCHLORIDE. Hydrochloride. Reed Army
Institute
Research.
NDA 019591............ LARIAM.......... Mefloquine 250 mg.......... Tablet; Oral.... Hoffmann-La
Hydrochloride. Roche Inc.
NDA 019735............ FLOXIN.......... Ofloxacin....... 200 mg; 300 mg; Tablet; Oral.... Janssen
400 mg. Pharmaceuticals
, Inc.
NDA 019890............ STADOL.......... Butorphanol 1 mg/Spray...... Spray, Metered; Bristol-Myers
Tartrate. Nasal. Squibb Co.
NDA 020142............ CATAFLAM........ Diclofenac 50 mg........... Tablet; Oral.... Novartis
Potassium. Pharmaceuticals
Corp.
NDA 020254............ VOLTAREN-XR..... Diclofenac 100 mg.......... Extended-Release Ditto.
Sodium. Tablet; Oral.
NDA 020312............ UNIVASC......... Moexipril 7.5 mg; 15 mg... Tablet; Oral.... UCB, Inc.
Hydrochloride.
NDA 020346............ ZYRTEC.......... Cetirizine 5 mg/5 mL....... Syrup; Oral..... Johnson &
Hydrochloride. Johnson
Consumer Inc.
NDA 020584............ LODINE XL....... Etodolac........ 400 mg; 500 mg; Extended-Release Wyeth
600 mg. Tablet; Oral. Pharmaceuticals
Inc.
NDA 020625............ ALLEGRA......... Fexofenadine 60 mg........... Capsule; Oral... Sanofi-Aventis
Hydrochloride. U.S. LLC.
NDA 020729............ UNIRETIC........ Hydro 12.5 mg/7.5 mg; Tablet; Oral.... UCB, Inc.
chlorothiazide; 12.5 mg/15 mg;
Moexipril 25 mg/15 mg.
Hydrochloride.
NDA 021066............ ZADITOR......... Ketotifen EQ 0.025% Base.. Solution/Drops; Alcon
Fumarate. Ophthalmic. Pharmaceuticals
, Ltd.
NDA 021224............ RAZADYNE........ Galantamine 4 mg/mL......... Solution; Oral.. Janssen
Hydrobromide. Pharmaceuticals
, Inc.
NDA 021378............ COMBUNOX........ Ibuprofen; 400 mg; 5 mg.... Tablet; Oral.... Forest
Oxycodone Laboratories,
Hydrochloride. Inc.
NDA 021473............ CIPRO XR........ Ciprofloxacin; 212.6 mg; EQ Extended-Release Bayer HealthCare
Ciprofloxacin 287.5 mg Base; Tablet; Oral. Pharmaceuticals
Hydrochloride. 425.2 mg; EQ , Inc.
574.9 mg Base.
NDA 021606............ ZEMPLAR......... Paricalcitol.... 4 micrograms Capsule; Oral... AbbVie Inc.
(mcg).
NDA 021729............ ABILIFY......... Aripiprazole.... 10 mg and 15 mg. Tablet, Orally Otsuka
Disintegrating; Pharmaceutical
Oral. Co., Ltd.
[[Page 19737]]
NDA 050072............ PENBRITIN-S..... Ampicillin EQ 125 mg Base/ Injectable; Wyeth Ayerst
Sodium. Vial; EQ 250 mg Injection. Laboratories.
Base/Vial; EQ
500 mg Base/
Vial; EQ 1 gram
(g) Base/Vial;
EQ 2 g Base/
Vial; EQ 4 g
Base/Vial.
NDA 050309............ POLYCILLIN-N.... Ampicillin EQ 125 mg Base/ Injectable; Bristol
Sodium. Vial; EQ 250 mg Injection. Laboratories
Base/Vial; EQ Inc.
500 mg Base/
Vial; EQ 1 g
Base/Vial; EQ 2
g Base/Vial.
NDA 050674............ VANTIN.......... Cefpodoxime EQ 100 mg Base; Tablet; Oral.... Pharmacia and
Proxetil. EQ 200 mg Base. Upjohn Co.
ANDA 064170........... CEFAZOLIN SODIUM Cefazolin Sodium EQ 10 g Base/ Injectable; Fresenius Kabi
Vial; EQ 20 g Injection. USA, LLC.
Base/Vial.
ANDA 075406........... OGESTREL 0.5/50- Ethinyl 0.05 mg; 0.5 mg. Tablet; Oral-21. Watson
21. Estradiol; Laboratories,
Norgestrel. Inc.
ANDA 085106........... PERCOCET........ Acetaminophen; 325 mg; 5 mg.... Tablet; Oral.... Vintage
Oxycodone Pharmaceuticals
Hydrochloride. LLC.
ANDA 089351........... ROXICET......... Acetaminophen; 325 mg/5 mL; 5 Solution; Oral.. West-Ward
Oxycodone mg/5 mL. Pharmaceuticals
Hydrochloride. International
Ltd.
ANDA 089456........... PERPHENAZINE.... Perphenazine.... 8 mg............ Tablet; Oral.... ANI
Pharmaceuticals
, Inc.
ANDA 089457........... PERPHENAZINE.... Perphenazine.... 16 mg........... Tablet; Oral.... Teva
Pharmaceuticals
USA.
ANDA 089707........... PERPHENAZINE.... Perphenazine.... 2 mg............ Tablet; Oral.... Ditto.
ANDA 089708........... PERPHENAZINE.... Perphenazine.... 4 mg............ Tablet; Oral.... Do.
----------------------------------------------------------------------------------------------------------------
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.
This is not a significant regulatory action subject to Executive
Order 12866, and does not impose any additional burden on regulated
entities.
Dated: April 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08582 Filed 4-27-17; 8:45 am]
BILLING CODE 4164-01-P
