[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Page 23269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0888]


Determination That FUNDUSCEIN-25 (fluorescein sodium injection), 
25%, and AK-FLUOR (fluorescein sodium injection), 25%, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 
FUNDUSCEIN-25 (fluorescein sodium injection), 25%, and AK-FLUOR 
(fluorescein sodium injection), 25%, were not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for fluorescein 
sodium injection, 25%, if all other legal and regulatory requirements 
are met.

FOR FURTHER INFORMATION CONTACT: Jane Inglese, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 6210, Silver Spring, MD 20993-0002, 301-
796-3601.

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 only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    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 ((21 CFR 314.161). FDA may not approve an ANDA that does not refer 
to a listed drug.
    FUNDUSCEIN-25 (fluorescein sodium injection), 25%, is the subject 
of NDA 17-869, held by Novartis Pharmaceuticals Corp., and initially 
approved on November 10, 1976. FUNDUSCEIN-25 is indicated for use in 
diagnostic fluorescein angiography or angioscopy of the retina and iris 
vasculature. AK-FLUOR (fluorescein sodium injection), 25%, is the 
subject of NDA 22-186, held by Akorn Inc., and initially approved on 
August 8, 2008. AK-FLUOR also is indicated for use in diagnostic 
fluorescein angiography or angioscopy of the retina and iris 
vasculature.
    FUNDUSCEIN-25 (fluorescein sodium injection), 25%, and AK-FLUOR 
(fluorescein sodium injection), 25%, are currently listed in the 
``Discontinued Drug Product List'' section of the Orange Book.
    Foley & Lardner LLP submitted a citizen petition dated December 7, 
2011 (Docket No. FDA-2011-P-0888), under 21 CFR 10.30, requesting that 
the Agency determine whether FUNDUSCEIN-25 (fluorescein sodium 
injection), 25%, was withdrawn from sale for reasons of safety or 
effectiveness. Although the citizen petition did not address AK-FLUOR 
(fluorescein sodium injection), 25%, that product has also been 
discontinued. On our own initiative, we have therefore also determined 
whether AK-FLUOR 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 FUNDUSCEIN-25 (fluorescein sodium 
injection), 25%, and AK-FLUOR (fluorescein sodium injection), 25%, were 
not withdrawn for reasons of safety or effectiveness. The petitioner 
has identified no data or other information suggesting that FUNDUSCEIN-
25 (fluorescein sodium injection), 25%, was withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of FUNDUSCEIN-25 (fluorescein sodium 
injection), 25%, and AK-FLUOR (fluorescein sodium injection), 25%, 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 FUNDUSCEIN-25 (fluorescein 
sodium injection), 25%, and AK-FLUOR (fluorescein sodium injection), 
25%, were not withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list FUNDUSCEIN-25 
(fluorescein sodium injection), 25%, and AK-FLUOR (fluorescein sodium 
injection), 25%, 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 FUNDUSCEIN-25 (fluorescein sodium injection), 25%, or AK-FLUOR 
(fluorescein sodium injection), 25%, 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 this drug 
product should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: April 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9292 Filed 4-17-12; 8:45 am]
BILLING CODE 4160-01-P