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Determination That XIBROM (Bromfenac Ophthalmic Solution) 0.09% Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) has determined that XIBROM (bromfenac ophthalmic solution) 0.09% was not withdrawn from sale for reasons of safety or effectiveness.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.

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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.

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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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness.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 (§ 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 § 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 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.

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Dated: May 9, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2011-11745 Filed 5-12-11; 8:45 am]