[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Units/Milliliter Polymyxin B Sulfate, Was Not Withdrawn From Sale for 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polymyxin B sulfate, was not withdrawn from sale for reasons of safety 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