82_FR_57204 82 FR 56974 - Determination That METICORTEN (Prednisone) Tablets, 1 Milligram and 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

82 FR 56974 - Determination That METICORTEN (Prednisone) Tablets, 1 Milligram and 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 230 (December 1, 2017)

Page Range56974-56975
FR Document2017-25900

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Administration (FDA or Agency) has determined that METICORTEN (prednisone) tablets, 1 milligram (mg) and 5 mg, were not withdrawn from sale for reasons of safety or effectiveness.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.

Federal Register, Volume 82 Issue 230 (Friday, December 1, 2017) 
[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Pages 56974-56975]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25900]


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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and 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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.

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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mg, were not withdrawn from sale for reasons of safety or 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, [email protected].

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

56974 Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices Agenda for TWU. Comments expressing do not have to repeat the extensive Diamond-Blackfan anemia, idiopathic support or with specific clinical testing otherwise necessary to thrombocytopenic purpura in adults, recommendations to improve the gain approval of a new drug application pure red cell aplasia, selected cases of Agenda are requested. A copy of the (NDA). secondary thrombocytopenia; draft Agenda is available at https:// The 1984 amendments include what 6. Miscellaneous: Trichinosis with www.regulations.gov (see Docket is now section 505(j)(7) of the Federal neurologic or myocardial involvement, Number CDC–2017–0114). Food, Drug, and Cosmetic Act (21 U.S.C. tuberculous meningitis with 355(j)(7)), which requires FDA to subarachnoid block or impending block John Howard, publish a list of all approved drugs. when used with appropriate Director, National Institute for Occupational FDA publishes this list as part of the antituberculous chemotherapy; Safety and Health, Centers for Disease Control ‘‘Approved Drug Products With 7. Neoplastic diseases: For the and Prevention. Therapeutic Equivalence Evaluations,’’ palliative management of leukemias and [FR Doc. 2017–25876 Filed 11–30–17; 8:45 am] which is known generally as the lymphomas; BILLING CODE 4163–19–P ‘‘Orange Book.’’ Under FDA regulations, 8. Nervous system: Acute drugs are removed from the list if the exacerbations of multiple sclerosis; Agency withdraws or suspends cerebral edema associated with primary DEPARTMENT OF HEALTH AND approval of the drug’s NDA or ANDA or metastatic brain tumor, craniotomy, HUMAN SERVICES for reasons of safety or effectiveness or or head injury; if FDA determines that the listed drug 9. Ophthalmic diseases: Sympathetic Food and Drug Administration ophthalmia, temporal arteritis, uveitis was withdrawn from sale for reasons of [Docket No. FDA–2017–P–4027] safety or effectiveness (21 CFR 314.162). and ocular inflammatory conditions A person may petition the Agency to unresponsive to topical corticosteroids; Determination That METICORTEN determine, or the Agency may 10. Renal diseases: To induce diuresis (Prednisone) Tablets, 1 Milligram and 5 determine on its own initiative, whether or remission of proteinuria in idiopathic Milligrams, Were Not Withdrawn From a listed drug was withdrawn from sale nephrotic syndrome or that due to lupus Sale for Reasons of Safety or for reasons of safety or effectiveness. erythematosus; Effectiveness This determination may be made at any 11. Respiratory diseases: Berylliosis, time after the drug has been withdrawn fulminating or disseminated pulmonary AGENCY: Food and Drug Administration, from sale, but must be made prior to tuberculosis when used concurrently HHS. approving an ANDA that refers to the with appropriate antituberculous ACTION: Notice. chemotherapy, idiopathic eosinophilic listed drug (§ 314.161 (21 CFR 314.161)). SUMMARY: The Food and Drug FDA may not approve an ANDA that pneumonias, symptomatic sarcoidosis; Administration (FDA or Agency) has does not refer to a listed drug. and determined that METICORTEN METICORTEN (prednisone) tablets, 1 12. Rheumatic disorders: As (prednisone) tablets, 1 milligram (mg) mg and 5 mg, are the subject of NDA adjunctive therapy for short-term and 5 mg, were not withdrawn from sale 09–766, held by Schering Corporation administration (to tide the patient over for reasons of safety or effectiveness. (Schering), and initially approved on an acute episode or exacerbation) in This determination means that FDA will February 21, 1955. METICORTEN is acute gouty arthritis; acute rheumatic not begin procedures to withdraw indicated for the following: carditis; ankylosing spondylitis; approval of abbreviated new drug 1. Allergic states: Control of severe or psoriatic arthritis; rheumatoid arthritis, applications (ANDAs) that refer to this incapacitating allergic conditions including juvenile rheumatoid arthritis drug product, and it will allow FDA to intractable to adequate trials of (selected cases may require low-dose continue to approve ANDAs that refer to conventional treatment in asthma, maintenance therapy). For the treatment the product as long as they meet atopic dermatitis, contact dermatitis, of dermatomyositis, polymyositis, and relevant legal and regulatory drug hypersensitivity reactions, systemic lupus erythematosus. requirements. perennial or seasonal allergic rhinitis, In a letter dated November 1, 2001, serum sickness; Schering requested withdrawal of NDA FOR FURTHER INFORMATION CONTACT: 2. Dermatologic diseases: Bullous 09–766 for METICORTEN (prednisone). Meadow Platt, Center for Drug dermatitis herpetiformis, exfoliative In the Federal Register of October 10, Evaluation and Research, Food and erythroderma, mycosis fungoides, 2002 (67 FR 63107), FDA announced Drug Administration, 10903 New pemphigus, severe erythema multiforme that it was withdrawing approval of Hampshire Ave., Bldg. 51, Rm. 6228, (Stevens-Johnson syndrome); NDA 09–766, effective November 12, Silver Spring, MD 20993–0002, 301– 3. Endocrine disorders: Primary or 2002. 796–1830, Meadow.Platt@fda.hhs.gov. secondary adrenocortical insufficiency Strides Pharma, Inc., submitted a SUPPLEMENTARY INFORMATION: In 1984, (hydrocortisone or cortisone is the drug citizen petition dated July 1, 2017 Congress enacted the Drug Price of choice; synthetic analogs may be used (Docket No. FDA–2017–P–4027), under Competition and Patent Term in conjunction with mineralocorticoids 21 CFR 10.30, requesting that the Restoration Act of 1984 (Pub. L. 98–417) where applicable; in infancy, Agency determine whether (the 1984 amendments), which mineralocorticoid supplementation is of METICORTEN (prednisone) tablets, 1 authorized the approval of duplicate particular importance), congenital mg and 5 mg, were withdrawn from sale versions of drug products under an adrenal hyperplasia, hypercalcemia for reasons of safety or effectiveness. ANDA procedure. ANDA applicants After considering the citizen petition sradovich on DSK3GMQ082PROD with NOTICES associated with cancer, nonsuppurative must, with certain exceptions, show that thyroiditis; and reviewing Agency records and the drug for which they are seeking 4. Gastrointestinal diseases: To tide based on the information we have at this approval contains the same active the patient over a critical period of the time, FDA has determined under ingredient in the same strength and disease in regional enteritis and § 314.161 that METICORTEN dosage form as the ‘‘listed drug,’’ which ulcerative colitis; (prednisone) tablets, 1 mg and 5 mg, is a version of the drug that was 5. Hematologic disorders: Acquired were not withdrawn for reasons of previously approved. ANDA applicants (autoimmune) hemolytic anemia, safety or effectiveness. The petitioner VerDate Sep<11>2014 16:44 Nov 30, 2017 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\01DEN1.SGM 01DEN1

Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices 56975 has identified no data or other FDA’s regulatory issues. The meeting comments, that information will be information suggesting that these will be open to the public. FDA is posted on https://www.regulations.gov. products were withdrawn for reasons of establishing a docket for public • If you want to submit a comment safety or effectiveness. We have comment on this document. with confidential information that you carefully reviewed our files for records DATES: The meeting will be held on do not wish to be made available to the concerning the withdrawal of January 11, 2018, from 8:30 a.m. to 4 public, submit the comment as a METICORTEN (prednisone) tablets, 1 p.m. written/paper submission and in the mg and 5 mg, from sale. We have also manner detailed (see ‘‘Written/Paper ADDRESSES: College Park Marriott Hotel Submissions’’ and ‘‘Instructions’’). independently evaluated relevant and Conference Center, Chesapeake literature and data for possible Written/Paper Submissions Ballroom, 3501 University Blvd. East, postmarketing adverse events. We have Hyattsville, MD 20783. The conference Submit written/paper submissions as reviewed the available evidence and center’s telephone number is 301–985– follows: determined that this drug product was not withdrawn from sale for reasons of 7300. Answers to commonly asked • Mail/Hand delivery/Courier (for questions about FDA Advisory written/paper submissions): Dockets safety or effectiveness. Committee meetings may be accessed at: Management Staff (HFA–305), Food and Accordingly, the Agency will https://www.fda.gov/Advisory Drug Administration, 5630 Fishers continue to list METICORTEN Committees/AboutAdvisoryCommittees/ Lane, Rm. 1061, Rockville, MD 20852. (prednisone) tablets, 1 mg and 5 mg, in • For written/paper comments ucm408555.htm. the ‘‘Discontinued Drug Product List’’ submitted to the Dockets Management FDA is establishing a docket for section of the Orange Book. The Staff, FDA will post your comment, as public comment on this meeting. The ‘‘Discontinued Drug Product List’’ well as any attachments, except for docket number is FDA–2017–N–6293. delineates, among other items, drug information submitted, marked and The docket will close on January 10, products that have been discontinued identified, as confidential, if submitted 2018. Submit either electronic or from marketing for reasons other than as detailed in ‘‘Instructions.’’ written comments on this public safety or effectiveness. FDA will not Instructions: All submissions received meeting by January 10, 2018. Please begin procedures to withdraw approval must include the Docket No. FDA– note that late, untimely filed comments of approved ANDAs that refer to this 2017–N–6293 for ‘‘Antimicrobial Drugs will not be considered. Electronic drug product. Additional ANDAs for Advisory Committee; Notice of Meeting; comments must be submitted on or this drug product may also be approved Establishment of a Public Docket; before January 10, 2018. The https:// by the Agency as long as they meet all Request for Comments.’’ Received www.regulations.gov electronic filing other legal and regulatory requirements comments, those filed in a timely system will accept comments until for the approval of ANDAs. If FDA manner (see ADDRESSES), will be placed midnight Eastern Time at the end of determines that labeling for this drug in the docket and, except for those January 10, 2018. Comments received by product should be revised to meet submitted as ‘‘Confidential mail/hand delivery/courier (for written/ current standards, the Agency will Submissions,’’ publicly viewable at paper submissions) will be considered advise ANDA applicants to submit such https://www.regulations.gov or at the timely if they are postmarked or the labeling. Dockets Management Staff between 9 delivery service acceptance receipt is on Dated: November 27, 2017. or before that date. a.m. and 4 p.m., Monday through Leslie Kux, Comments received on or before Friday. Associate Commissioner for Policy. December 27, 2017, will be provided to • Confidential Submissions—To [FR Doc. 2017–25900 Filed 11–30–17; 8:45 am] the committee. Comments received after submit a comment with confidential that date will be taken into information that you do not wish to be BILLING CODE 4164–01–P consideration by the Agency. made publicly available, submit your You may submit comments as comments only as a written/paper DEPARTMENT OF HEALTH AND follows: submission. You should submit two HUMAN SERVICES copies total. One copy will include the Electronic Submissions information you claim to be confidential Food and Drug Administration Submit electronic comments in the with a heading or cover note that states following way: ‘‘THIS DOCUMENT CONTAINS [Docket No. FDA–2017–N–6293] • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The https://www.regulations.gov. Follow the Agency will review this copy, including Antimicrobial Drugs Advisory instructions for submitting comments. the claimed confidential information, in Committee; Notice of Meeting; Comments submitted electronically, its consideration of comments. The Establishment of a Public Docket; including attachments, to https://www. second copy, which will have the Request for Comments regulations.gov will be posted to the claimed confidential information AGENCY: Food and Drug Administration, docket unchanged. Because your redacted/blacked out, will be available HHS. comment will be made public, you are for public viewing and posted on ACTION: Notice; establishment of a solely responsible for ensuring that your https://www.regulations.gov. Submit public docket; request for comments. comment does not include any both copies to the Dockets Management confidential information that you or a Staff. If you do not wish your name and SUMMARY: The Food and Drug third party may not wish to be posted, contact information to be made publicly sradovich on DSK3GMQ082PROD with NOTICES Administration (FDA or Agency) such as medical information, your or available, you can provide this announces a forthcoming public anyone else’s Social Security number, or information on the cover sheet and not advisory committee meeting of the confidential business information, such in the body of your comments and you Antimicrobial Drugs Advisory as a manufacturing process. Please note must identify the information as Committee. The general function of the that if you include your name, contact ‘‘confidential.’’ Any information marked committee is to provide advice and information, or other information that as ‘‘confidential’’ will not be disclosed recommendations to the Agency on identifies you in the body of your except in accordance with 21 CFR 10.20 VerDate Sep<11>2014 16:44 Nov 30, 2017 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\01DEN1.SGM 01DEN1


Document Created: 2018-10-25 10:44:47
Document Modified: 2018-10-25 10:44:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactMeadow 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, [email protected]
FR Citation82 FR 56974 
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