Determination That Adderall (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 67365-67367 [2013-26856]
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Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Karen
Abraham-Burrell at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: November 5, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–26868 Filed 11–8–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK67QTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Circulatory
System Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 11, 2013, from 8 a.m.
to 6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900.
Contact Person: Jamie Waterhouse,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
VerDate Mar<15>2010
17:41 Nov 08, 2013
Jkt 232001
Spring, MD 20993, 301–796–3063, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On December 11, 2013, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application regarding the
Boston Scientific WATCHMAN Left
Atrial Appendage (LAA) Closure
Technology. The WATCHMAN LAA
Closure Technology is a percutaneously
delivered permanent cardiac implant
placed in the left atrial appendage. This
device is intended to prevent thrombus
embolization from the left atrial
appendage, thereby preventing the
occurrence of ischemic stroke and
systemic embolism, and reduce the risk
of life-threatening bleeding events in
patients with non-valvular atrial
fibrillation who are eligible for warfarin
therapy.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 27, 2013.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
PO 00000
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67365
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 19, 2013. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 20, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Ann Marie
Williams, Conference Management
Staff, at AnnMarie.Williams@
fda.hhs.gov or 301–796–5966 at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: November 5, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–26891 Filed 11–8–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1361]
Determination That Adderall
(Amphetamine Aspartate;
Amphetamine Sulfate;
Dextroamphetamine Saccharate;
Dextroamphetamine Sulfate) Tablet
and 13 Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\12NON1.SGM
Notice.
12NON1
67366
Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices
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. 6207,
Silver Spring, MD 20993–0002, 301–
796–5418.
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
sponsors 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. Sponsors of
ANDAs 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 011522 ........................
ADDERALL (amphetamine aspartate; amphetamine
sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate) Tablet; Oral, 5 milligrams (mg),
7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg.
KENALOG (triamcinolone acetonide) Cream; Topical,
0.025%, 0.1%.
MUCOMYST (acetylcysteine) Solution; Inhalation, Oral,
10%, 20%.
NITROGLYCERIN (nitroglycerin) Injectable; Injection,
5mg/milliliter (mL).
WESTCORT (hydrocortisone valerate) Ointment; Topical, 0.2%.
TAMBOCOR (flecainide acetate) Tablet; Oral, 50 mg,
100 mg, 150 mg.
DYNACIRC CR (isradipine) Tablet; Extended Release,
Oral, 5 mg, 10 mg.
RETROVIR (zidovudine) Tablet; Oral, 300 mg ..............
Teva Womens Health Inc., 41 Moores Rd., P.O. Box
4011, Frazer, PA 19355.
NDA 011601 ........................
NDA 013601 ........................
NDA 018531 ........................
NDA 018726 ........................
NDA 018830 ........................
NDA 020336 ........................
NDA 020518 ........................
NDA 021745 ........................
ANDA 081295 ......................
RYZOLT (tramadol HCl) Tablet; Extended Release,
Oral, 100 mg, 200 mg, 300 mg.
ALTACE (ramipril) Tablet; Oral, 1.25 mg, 2.5 mg, 5 mg,
10 mg.
SOLODYN (minocycline HCl) Tablet; Extended Release; Equivalent to (EQ) 45 mg Base, EQ 90 mg
Base, EQ 135 mg Base.
ESTRACE (estradiol) Tablet; Oral, 0.5 mg .....................
ANDA 084499 ......................
ANDA 084500 ......................
ESTRACE (estradiol) Tablet; Oral, 1 mg ........................
ESTRACE (estradiol) Tablet; Oral, 2 mg ........................
NDA 022021 ........................
emcdonald on DSK67QTVN1PROD with NOTICES
NDA 050808 ........................
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
VerDate Mar<15>2010
17:41 Nov 08, 2013
Jkt 232001
Apothecon Pharmaceuticals, General Offices, P.O. Box
4500, Princeton, NJ 08543–4500.
Do.
Hospira Inc., 275 North Field Dr., Bldg. H2, Lake Forest, IL 60045–5046.
Ranbaxy Inc., 600 College Rd., East Princeton, NJ
08540.
Medicis Pharmaceutical Corp., 7720 North Dobson Rd.,
Scottsdale, AZ 85256.
GlaxoSmithKline LLC., 2711 Centerville Rd., Ste. 400,
Wilmington, DE 19808.
ViiV Healthcare, 5 Moore Dr., Research Triangle Park,
NC 27709.
Purdue Pharma Products LP, 1 Stamford Forum, Stamford, CT 06901.
Pfizer Inc., 501 5th St., Bristol, TN 37620.
Medicis Pharmaceutical Corp., 7720 North Dobson Rd.,
Scottsdale, AZ 85256.
Bristol Myers Squibb, P.O. Box 4000, Princeton, NJ
08543.
Do.
Do.
‘‘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.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\12NON1.SGM
12NON1
67367
Federal Register / Vol. 78, No. 218 / Tuesday, November 12, 2013 / Notices
Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
[FR Doc. 2013–26856 Filed 11–8–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Information Collection Request Title:
Ryan White HIV/AIDS Program Core
Medical Services Waiver Application
Requirements
Health Resources and Services
Administration
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
SUMMARY:
OMB No. 0915–0307—Revision
Abstract: Title XXVI of the Public
Health Service (PHS) Act, as amended
by the Ryan White HIV/AIDS Treatment
Extension Act of 2009 (Ryan White HIV/
AIDS Program), Part A section 2604(c),
Part B section 2612(b), and Part C
section 2651(c), requires that grantees
expend 75 percent of Parts A, B, and C
funds on core medical services,
including antiretroviral drugs for
individuals with HIV/AIDS, identified
and eligible under the legislation. In
order for grantees under Parts A, B, and
C to be exempted from the 75 percent
core medical services requirement, they
must request and receive a waiver from
HRSA, as required in the Act.
On October 25, 2013, HRSA
published revised standards for core
medical services waiver requests in the
Federal Register (78 FR 63990). These
revised standards will allow grantees
more flexibility to adjust resource
allocation based on the current situation
in their local environment. These
standards ensure that grantees receiving
waivers demonstrate the availability of
core medical services, including
antiretroviral drugs, for persons with
HIV/AIDS served under Title XXVI of
the PHS Act. The core medical services
waiver uniform standard and waiver
request process will apply to Ryan
White HIV/AIDS Program Grant Awards
under Parts A, B, and C of Title XXVI
of the PHS Act. Core medical services
Number of
respondents
Form name
Number of
responses per
respondent
waivers will be effective for a 1-year
period that is consistent with the grant
award period. Grantees may submit a
waiver request before the annual grant
application, with the application, or up
to 4 months after the grant award has
been made.
Need and Proposed Use of the
Information: HRSA uses the
documentation submitted in core
medical services waiver requests to
determine if the applicant/grantee meets
the statutory requirements for waiver
eligibility including: (1) No waiting lists
for AIDS Drug Assistance Program
(ADAP) services; and (2) evidence of
core medical services availability within
the grantee’s jurisdiction, state, or
service area to all individuals with HIV/
AIDS identified and eligible under Title
XXVI of the PHS Act. See sections
2604(c)(2), 2612(b)(2), and 2651(c)(2) of
the PHS Act.
Likely Respondents: Ryan White HIV/
AIDS Program Part A, B, and C grantees.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
20
1
20
5.5
110
Total ..............................................................................
emcdonald on DSK67QTVN1PROD with NOTICES
Waiver Request ...................................................................
20
1
20
5.5
110
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
VerDate Mar<15>2010
17:41 Nov 08, 2013
Jkt 232001
or other forms of information
technology to minimize the information
collection burden.
PO 00000
Dated: November 4, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–26974 Filed 11–8–13; 8:45 am]
BILLING CODE 4165–15–P
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E:\FR\FM\12NON1.SGM
12NON1
]]>Agencies
[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67365-67367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26856]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1361]
Determination That Adderall (Amphetamine Aspartate; Amphetamine
Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate)
Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 67366]]
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. 6207, Silver Spring, MD 20993-0002, 301-
796-5418.
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
sponsors 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. Sponsors of ANDAs 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 011522.................. ADDERALL Teva Womens Health
(amphetamine Inc., 41 Moores
aspartate; Rd., P.O. Box 4011,
amphetamine Frazer, PA 19355.
sulfate;
dextroamphetamine
saccharate;
dextroamphetamine
sulfate) Tablet;
Oral, 5 milligrams
(mg), 7.5 mg, 10
mg, 12.5 mg, 15 mg,
20 mg, 30 mg.
NDA 011601.................. KENALOG Apothecon
(triamcinolone Pharmaceuticals,
acetonide) Cream; General Offices,
Topical, 0.025%, P.O. Box 4500,
0.1%. Princeton, NJ 08543-
4500.
NDA 013601.................. MUCOMYST Do.
(acetylcysteine)
Solution;
Inhalation, Oral,
10%, 20%.
NDA 018531.................. NITROGLYCERIN Hospira Inc., 275
(nitroglycerin) North Field Dr.,
Injectable; Bldg. H2, Lake
Injection, 5mg/ Forest, IL 60045-
milliliter (mL). 5046.
NDA 018726.................. WESTCORT Ranbaxy Inc., 600
(hydrocortisone College Rd., East
valerate) Ointment; Princeton, NJ
Topical, 0.2%. 08540.
NDA 018830.................. TAMBOCOR (flecainide Medicis
acetate) Tablet; Pharmaceutical
Oral, 50 mg, 100 Corp., 7720 North
mg, 150 mg. Dobson Rd.,
Scottsdale, AZ
85256.
NDA 020336.................. DYNACIRC CR GlaxoSmithKline
(isradipine) LLC., 2711
Tablet; Extended Centerville Rd.,
Release, Oral, 5 Ste. 400,
mg, 10 mg. Wilmington, DE
19808.
NDA 020518.................. RETROVIR ViiV Healthcare, 5
(zidovudine) Moore Dr., Research
Tablet; Oral, 300 Triangle Park, NC
mg. 27709.
NDA 021745.................. RYZOLT (tramadol Purdue Pharma
HCl) Tablet; Products LP, 1
Extended Release, Stamford Forum,
Oral, 100 mg, 200 Stamford, CT 06901.
mg, 300 mg.
NDA 022021.................. ALTACE (ramipril) Pfizer Inc., 501 5th
Tablet; Oral, 1.25 St., Bristol, TN
mg, 2.5 mg, 5 mg, 37620.
10 mg.
NDA 050808.................. SOLODYN (minocycline Medicis
HCl) Tablet; Pharmaceutical
Extended Release; Corp., 7720 North
Equivalent to (EQ) Dobson Rd.,
45 mg Base, EQ 90 Scottsdale, AZ
mg Base, EQ 135 mg 85256.
Base.
ANDA 081295................. ESTRACE (estradiol) Bristol Myers
Tablet; Oral, 0.5 Squibb, P.O. Box
mg. 4000, Princeton, NJ
08543.
ANDA 084499................. ESTRACE (estradiol) Do.
Tablet; Oral, 1 mg.
ANDA 084500................. ESTRACE (estradiol) Do.
Tablet; Oral, 2 mg.
------------------------------------------------------------------------
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.
[[Page 67367]]
Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26856 Filed 11-8-13; 8:45 am]
BILLING CODE 4160-01-P
