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and 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or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mg, were not withdrawn from sale for reasons of safety or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