[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]


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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and 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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mg, were not withdrawn from sale for reasons of safety or 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


