[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13304-13305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06549]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-3883]
Determination That CORTISPORIN (Hydrocortisone/Neomycin Sulfate/
Polymyxin B Sulfate) Otic Solution, 10 Milligrams/Milliliter
Hydrocortisone, 3.5 Milligrams Base/Milliliter Neomycin Sulfate, 10,000
Units/Milliliter Polymyxin B Sulfate, Was Not Withdrawn From Sale for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 CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin
B sulfate) otic solution, 10 milligrams (mg)/milliliter (mL)
hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was not withdrawn from sale for reasons of safety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: Kate Greenwood, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240-
402-1748.
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.
CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone, 3.5 mg base/mL neomycin
sulfate, 10,000 units/mL polymyxin B sulfate, is the subject of NDA
050479, held by Monarch Pharmaceuticals LLC, and initially approved on
December 9, 1975. CORTISPORIN is indicated for the treatment of
superficial bacterial infections of the external auditory canal caused
by organisms susceptible to the action of the antibiotics.
CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone, 3.5 mg base/mL neomycin
sulfate, 10,000 units/mL polymyxin B sulfate, is currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book.
Foley & Lardner LLP submitted a citizen petition dated October 11,
2018 (Docket No. FDA-2018-P-3883), under Sec. 10.30 (21 CFR 10.30),
requesting that the Agency determine whether CORTISPORIN
(hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was 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 CORTISPORIN (hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10 mg/mL hydrocortisone, 3.5 mg
base/mL neomycin sulfate, 10,000 units/mL polymyxin B sulfate, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that CORTISPORIN
(hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of CORTISPORIN (hydrocortisone/neomycin
sulfate/polymyxin B sulfate) otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate, 10,000 units/mL polymyxin B sulfate,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have found no
information that would indicate that this drug product was withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list CORTISPORIN
(hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, 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.
[[Page 13305]]
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06549 Filed 4-3-19; 8:45 am]
BILLING CODE 4164-01-P