[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]
-----------------------------------------------------------------------
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and 0.05%, Were Not Withdrawn From Sale for Reasons of Safety or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.
-----------------------------------------------------------------------
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withdrawn from sale for reasons of safety or effectiveness.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drug was withdrawn from sale for reasons of safety or effectiveness (21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