[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Page 58421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-2659]


Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams, 
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 or Agency) has 
determined that NOROXIN (norfloxacin) tablets, 400 milligrams (mg), was 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for norfloxacin tablets, 400 mg, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-
402-0978.

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drug was withdrawn from sale for reasons of safety or effectiveness (21 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 (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    NOROXIN (norfloxacin) tablets, 400 mg, is the subject of NDA 
019384, held by Merck & Company, Inc. (Merck), and initially approved 
on October 31, 1986. NOROXIN is indicated for the treatment of adults 
with the following infections caused by susceptible strains of certain 
designated microorganisms: Uncomplicated urinary tract infections 
(including cystitis), uncomplicated urethral and cervical gonorrhea, 
and prostatitis.
    In a letter dated October 13, 2015, Merck notified FDA that NOROXIN 
(norfloxacin) tablets, 400 mg, was being discontinued, and FDA moved 
the drug product to the ``Discontinued Drug Product List'' section of 
the Orange Book. In the Federal Register of October 4, 2016 (81 FR 
68427), FDA announced that it was withdrawing approval of NDA 019384, 
effective November 3, 2016.
    Jubilant Generics Ltd. submitted a citizen petition dated April 27, 
2017 (Docket No. FDA-2017-P-2659), under 21 CFR 10.30, requesting that 
the Agency determine whether NOROXIN (norfloxacin) tablets, 400 mg, 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 Sec.  314.161 that NOROXIN (norfloxacin) tablets, 400 mg, was not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that NOROXIN 
(norfloxacin) tablets, 400 mg, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of NOROXIN (norfloxacin) tablets, 400 mg, 
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 this drug product was not 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list NOROXIN (norfloxacin) 
tablets, 400 mg, 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 NOROXIN (norfloxacin) tablets, 400 mg, 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, the Agency will advise ANDA applicants 
to submit such labeling.

    Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26693 Filed 12-11-17; 8:45 am]
 BILLING CODE 4164-01-P