[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Notices]
[Pages 28045-28046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11745]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0128]


Determination That XIBROM (Bromfenac Ophthalmic Solution) 0.09% 
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 
XIBROM (bromfenac ophthalmic solution) 0.09% was not withdrawn from 
sale for reasons of safety or effectiveness. This determination will 
allow FDA to approve abbreviated new drug applications (ANDAs) for 
bromfenac ophthalmic solution 0.09% if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.

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, a drug is 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.
    XIBROM (bromfenac ophthalmic solution) 0.09% is the subject of NDA 
021664 held by ISTA Pharmaceuticals, Inc. (Ista), approved March 24, 
2005. XIBROM is a topical nonsteroidal anti-inflammatory drug for the 
treatment of postoperative inflammation and reduction of ocular pain in 
patients who have undergone cataract extraction.
    In a citizen petition dated March 1, 2011, and in a letter dated 
March 3, 2011, Ista informed FDA that it had discontinued shipping 
XIBROM (bromfenac ophthalmic solution) 0.09% as of February 28, 2011. 
Ista took the position that XIBROM (bromfenac ophthalmic solution) 
0.09% had been discontinued for safety reasons.
    After considering the citizen petition and reviewing Agency 
records, FDA determined under Sec.  314.161 that XIBROM (bromfenac 
ophthalmic solution) 0.09% was not withdrawn for reasons of safety or 
effectiveness. We described the basis for this determination in our 
letter response to Ista's citizen petition (available on http://www.regulations.gov under Docket No. FDA-2011-P-0128).
    Accordingly, the Agency will continue to list XIBROM (bromfenac 
ophthalmic solution) 0.09% 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 XIBROM (bromfenac ophthalmic 
solution) 0.09% 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.


[[Page 28046]]


    Dated: May 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11745 Filed 5-12-11; 8:45 am]
BILLING CODE 4160-01-P