[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Notices]
[Pages 35038-35039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13782]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0113]


Determination That CORDRAN (Flurandrenolide) Ointment USP, 0.025% 
and 0.05%, Were Not Withdrawn From Sale for Reasons of Safety or 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) has determined that 
CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for

[[Page 35039]]

flurandrenolide ointment, 0.025% and 0.05%, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Christine Kirk, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-2465.

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drug was withdrawn from sale for reasons of safety or effectiveness (21 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.
    CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, are the 
subject of NDA 012806, held by Aqua Pharmaceuticals, and initially 
approved on October 18, 1965. CORDRAN Ointment is a topical 
corticosteroid indicated for the relief of the inflammatory and 
pruritic manifestations of corticosteroid-responsive dermatoses.
    CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, are 
currently listed in the ``Discontinued Drug Product List'' section of 
the Orange Book.
    IGI Labs, Inc., submitted a citizen petition dated January 15, 2013 
(Docket No. FDA-2013-P-0113), under 21 CFR 10.30, requesting that the 
Agency determine whether CORDRAN (flurandrenolide) Ointment USP, 0.05%, 
was voluntarily withdrawn or withheld from sale for reasons of safety 
or effectiveness. Although the citizen petition did not address the 
0.025% strength, that strength has also been discontinued. On our own 
initiative, we have also determined whether that strength was withdrawn 
for safety or effectiveness reasons.
    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 CORDRAN (flurandrenolide) Ointment USP, 0.025% 
and 0.05%, were not withdrawn for reasons of safety or effectiveness. 
The petitioner has identified no data or other information suggesting 
that CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, were 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of CORDRAN 
(flurandrenolide) Ointment USP, 0.025% and 0.05%, 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 these products were withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list CORDRAN 
(flurandrenolide) Ointment USP, 0.025% and 0.05%, 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. ANDAs that refer to CORDRAN (flurandrenolide) Ointment 
USP, 0.025% or 0.05%, may 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 these drug products should 
be revised to meet current standards, the Agency will advise ANDA 
applicants to submit such labeling.

    Dated: June 6, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-13782 Filed 6-10-13; 8:45 am]
BILLING CODE 4160-01-P