Determination That METICORTEN (Prednisone) Tablets, 1 Milligram and 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 56974-56975 [2017-25900]
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56974
Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
Agenda for TWU. Comments expressing
support or with specific
recommendations to improve the
Agenda are requested. A copy of the
draft Agenda is available at https://
www.regulations.gov (see Docket
Number CDC–2017–0114).
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2017–25876 Filed 11–30–17; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–4027]
Determination That METICORTEN
(Prednisone) Tablets, 1 Milligram and 5
Milligrams, Were Not Withdrawn From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 METICORTEN
(prednisone) tablets, 1 milligram (mg)
and 5 mg, were not withdrawn from sale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 this
drug product, and it will allow FDA to
continue to approve ANDAs that refer to
the product as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Meadow Platt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
796–1830, Meadow.Platt@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 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
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:44 Nov 30, 2017
Jkt 244001
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 known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are 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).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
METICORTEN (prednisone) tablets, 1
mg and 5 mg, are the subject of NDA
09–766, held by Schering Corporation
(Schering), and initially approved on
February 21, 1955. METICORTEN is
indicated for the following:
1. Allergic states: Control of severe or
incapacitating allergic conditions
intractable to adequate trials of
conventional treatment in asthma,
atopic dermatitis, contact dermatitis,
drug hypersensitivity reactions,
perennial or seasonal allergic rhinitis,
serum sickness;
2. Dermatologic diseases: Bullous
dermatitis herpetiformis, exfoliative
erythroderma, mycosis fungoides,
pemphigus, severe erythema multiforme
(Stevens-Johnson syndrome);
3. Endocrine disorders: Primary or
secondary adrenocortical insufficiency
(hydrocortisone or cortisone is the drug
of choice; synthetic analogs may be used
in conjunction with mineralocorticoids
where applicable; in infancy,
mineralocorticoid supplementation is of
particular importance), congenital
adrenal hyperplasia, hypercalcemia
associated with cancer, nonsuppurative
thyroiditis;
4. Gastrointestinal diseases: To tide
the patient over a critical period of the
disease in regional enteritis and
ulcerative colitis;
5. Hematologic disorders: Acquired
(autoimmune) hemolytic anemia,
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Diamond-Blackfan anemia, idiopathic
thrombocytopenic purpura in adults,
pure red cell aplasia, selected cases of
secondary thrombocytopenia;
6. Miscellaneous: Trichinosis with
neurologic or myocardial involvement,
tuberculous meningitis with
subarachnoid block or impending block
when used with appropriate
antituberculous chemotherapy;
7. Neoplastic diseases: For the
palliative management of leukemias and
lymphomas;
8. Nervous system: Acute
exacerbations of multiple sclerosis;
cerebral edema associated with primary
or metastatic brain tumor, craniotomy,
or head injury;
9. Ophthalmic diseases: Sympathetic
ophthalmia, temporal arteritis, uveitis
and ocular inflammatory conditions
unresponsive to topical corticosteroids;
10. Renal diseases: To induce diuresis
or remission of proteinuria in idiopathic
nephrotic syndrome or that due to lupus
erythematosus;
11. Respiratory diseases: Berylliosis,
fulminating or disseminated pulmonary
tuberculosis when used concurrently
with appropriate antituberculous
chemotherapy, idiopathic eosinophilic
pneumonias, symptomatic sarcoidosis;
and
12. Rheumatic disorders: As
adjunctive therapy for short-term
administration (to tide the patient over
an acute episode or exacerbation) in
acute gouty arthritis; acute rheumatic
carditis; ankylosing spondylitis;
psoriatic arthritis; rheumatoid arthritis,
including juvenile rheumatoid arthritis
(selected cases may require low-dose
maintenance therapy). For the treatment
of dermatomyositis, polymyositis, and
systemic lupus erythematosus.
In a letter dated November 1, 2001,
Schering requested withdrawal of NDA
09–766 for METICORTEN (prednisone).
In the Federal Register of October 10,
2002 (67 FR 63107), FDA announced
that it was withdrawing approval of
NDA 09–766, effective November 12,
2002.
Strides Pharma, Inc., submitted a
citizen petition dated July 1, 2017
(Docket No. FDA–2017–P–4027), under
21 CFR 10.30, requesting that the
Agency determine whether
METICORTEN (prednisone) tablets, 1
mg and 5 mg, were withdrawn from sale
for reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that METICORTEN
(prednisone) tablets, 1 mg and 5 mg,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
E:\FR\FM\01DEN1.SGM
01DEN1
Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
has identified no data or other
information suggesting that these
products were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
METICORTEN (prednisone) tablets, 1
mg and 5 mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list METICORTEN
(prednisone) tablets, 1 mg and 5 mg, in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: November 27, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25900 Filed 11–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2017–N–6293]
Antimicrobial Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
sradovich on DSK3GMQ082PROD with NOTICES
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Antimicrobial Drugs Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
SUMMARY:
VerDate Sep<11>2014
16:44 Nov 30, 2017
Jkt 244001
College Park Marriott Hotel
and Conference Center, Chesapeake
Ballroom, 3501 University Blvd. East,
Hyattsville, MD 20783. The conference
center’s telephone number is 301–985–
7300. Answers to commonly asked
questions about FDA Advisory
Committee meetings may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–6293.
The docket will close on January 10,
2018. Submit either electronic or
written comments on this public
meeting by January 10, 2018. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before January 10, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
January 10, 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.
Comments received on or before
December 27, 2017, will be provided to
the committee. Comments received after
that date will be taken into
consideration by the Agency.
You may submit comments as
follows:
ADDRESSES:
Electronic Submissions
Food and Drug Administration
AGENCY:
FDA’s regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
DATES: The meeting will be held on
January 11, 2018, from 8:30 a.m. to 4
p.m.
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
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56975
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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 No. FDA–
2017–N–6293 for ‘‘Antimicrobial Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify the information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
E:\FR\FM\01DEN1.SGM
01DEN1
]]>Agencies
[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Pages 56974-56975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25900]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-4027]
Determination That METICORTEN (Prednisone) Tablets, 1 Milligram
and 5 Milligrams, 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 METICORTEN (prednisone) tablets, 1 milligram (mg) and 5
mg, 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 this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Meadow Platt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
796-1830, Meadow.Platt@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 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 known generally as the ``Orange
Book.'' Under FDA regulations, drugs are 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).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
METICORTEN (prednisone) tablets, 1 mg and 5 mg, are the subject of
NDA 09-766, held by Schering Corporation (Schering), and initially
approved on February 21, 1955. METICORTEN is indicated for the
following:
1. Allergic states: Control of severe or incapacitating allergic
conditions intractable to adequate trials of conventional treatment in
asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity
reactions, perennial or seasonal allergic rhinitis, serum sickness;
2. Dermatologic diseases: Bullous dermatitis herpetiformis,
exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema
multiforme (Stevens-Johnson syndrome);
3. Endocrine disorders: Primary or secondary adrenocortical
insufficiency (hydrocortisone or cortisone is the drug of choice;
synthetic analogs may be used in conjunction with mineralocorticoids
where applicable; in infancy, mineralocorticoid supplementation is of
particular importance), congenital adrenal hyperplasia, hypercalcemia
associated with cancer, nonsuppurative thyroiditis;
4. Gastrointestinal diseases: To tide the patient over a critical
period of the disease in regional enteritis and ulcerative colitis;
5. Hematologic disorders: Acquired (autoimmune) hemolytic anemia,
Diamond-Blackfan anemia, idiopathic thrombocytopenic purpura in adults,
pure red cell aplasia, selected cases of secondary thrombocytopenia;
6. Miscellaneous: Trichinosis with neurologic or myocardial
involvement, tuberculous meningitis with subarachnoid block or
impending block when used with appropriate antituberculous
chemotherapy;
7. Neoplastic diseases: For the palliative management of leukemias
and lymphomas;
8. Nervous system: Acute exacerbations of multiple sclerosis;
cerebral edema associated with primary or metastatic brain tumor,
craniotomy, or head injury;
9. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis,
uveitis and ocular inflammatory conditions unresponsive to topical
corticosteroids;
10. Renal diseases: To induce diuresis or remission of proteinuria
in idiopathic nephrotic syndrome or that due to lupus erythematosus;
11. Respiratory diseases: Berylliosis, fulminating or disseminated
pulmonary tuberculosis when used concurrently with appropriate
antituberculous chemotherapy, idiopathic eosinophilic pneumonias,
symptomatic sarcoidosis; and
12. Rheumatic disorders: As adjunctive therapy for short-term
administration (to tide the patient over an acute episode or
exacerbation) in acute gouty arthritis; acute rheumatic carditis;
ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis,
including juvenile rheumatoid arthritis (selected cases may require
low-dose maintenance therapy). For the treatment of dermatomyositis,
polymyositis, and systemic lupus erythematosus.
In a letter dated November 1, 2001, Schering requested withdrawal
of NDA 09-766 for METICORTEN (prednisone). In the Federal Register of
October 10, 2002 (67 FR 63107), FDA announced that it was withdrawing
approval of NDA 09-766, effective November 12, 2002.
Strides Pharma, Inc., submitted a citizen petition dated July 1,
2017 (Docket No. FDA-2017-P-4027), under 21 CFR 10.30, requesting that
the Agency determine whether METICORTEN (prednisone) tablets, 1 mg and
5 mg, were withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that METICORTEN (prednisone) tablets, 1 mg and 5
mg, were not withdrawn for reasons of safety or effectiveness. The
petitioner
[[Page 56975]]
has identified no data or other information suggesting that these
products were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
METICORTEN (prednisone) tablets, 1 mg and 5 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have reviewed the available evidence
and determined that this drug product was not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list METICORTEN
(prednisone) tablets, 1 mg and 5 mg, in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
Dated: November 27, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25900 Filed 11-30-17; 8:45 am]
BILLING CODE 4164-01-P
