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

###### Food and Drug Administration

          - [Docket No. FDA-2018-P-0327]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA or Agency) has determined that MUTAMYCIN (mitomycin) injectable, 5 milligrams (mg)/vial and 20 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, if all other legal and regulatory requirements are met.

# FOR FURTHER INFORMATION CONTACT:

                        Stacy Kane, Center for Drug Evaluation                               ( print page 27011)                            and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,                         *Stacy.Kane@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).

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of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness.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

MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, is the subject of NDA 050450, held by Bristol Laboratories Inc., and initially approved on May 28, 1974. MUTAMYCIN has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Fresenius Kabi USA, LLC submitted a citizen petition dated January 22, 2018 (Docket No. FDA-2018-P-0327), under 21 CFR 10.30, requesting that the Agency determine whether MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, 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 MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that this product was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, 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 MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies 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 approved ANDAs that refer to this drug product. Additional ANDAs for this drug product 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: June 5, 2018.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2018-12441 Filed 6-8-18; 8:45 am]

 BILLING CODE 4164-01-P