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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2021-P-0299]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA or Agency) has determined that EFUDEX (fluorouracil) topical solution, 5 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug application (ANDA) that refers to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

# FOR FURTHER INFORMATION CONTACT:

                        Kaetochi Okemgbo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6272, Silver Spring, MD 20993-0002, 240-825-9944,                         *Kaetochi.Okemgbo@fda.hhs.gov.*

# 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).                          ( print page 40567)    

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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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 (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

EFUDEX (fluorouracil) topical solution, 5 percent, is the subject of NDA 016831, held by Bausch Health Americas, Inc., and initially approved on July 29, 1970. EFUDEX is indicated for the topical treatment of multiple actinic or solar keratoses, and treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. EFUDEX (fluorouracil) topical solution, 5 percent, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Encube Ethicals Private Ltd. submitted a citizen petition dated March 16, 2021 (Docket No. FDA-2021-P-0299), under 21 CFR 10.30, requesting that the Agency determine whether EFUDEX (fluorouracil) topical solution, 5 percent, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that EFUDEX (fluorouracil) topical solution, 5 percent, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that EFUDEX (fluorouracil) topical solution, 5 percent, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of EFUDEX (fluorouracil) topical solution, 5 percent, 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 this drug product was withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list EFUDEX (fluorouracil) topical solution, 5 percent, 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. FDA will not begin procedures to withdraw approval of the approved ANDA that refers to this drug product. Additional ANDAs that refer to EFUDEX (fluorouracil) topical solution, 5 percent, may also 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: July 20, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

[FR Doc. 2021-16037 Filed 7-27-21; 8:45 am]

BILLING CODE 4164-01-P