[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Page 45507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-4224]


Determination That PARAFON FORTE DSC (Chlorzoxazone) Tablets, 500 
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 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 PARAFON FORTE DSC (chlorzoxazone) tablets, 500 
milligrams (mg), were not withdrawn from sale for reasons of safety or 
effectiveness. This determination means that FDA will not begin 
procedures to withdraw approval of abbreviated new drug applications 
(ANDAs) that refer to this drug product, and this determination will 
allow FDA to continue to approve ANDAs for chlorzoxane tablets, 500 mg, 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: David Faranda, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-8767.

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.
    PARAFON FORTE DSC (chlorzoxazone) tablets, 500 mg, is the subject 
of NDA 011529, held by Janssen Research & Development, LLC, and 
initially approved on August 15, 1958. PARAFON FORTE DSC is indicated 
as an adjunct to rest, physical therapy, and other measures for the 
relief of discomfort associated with acute, painful musculoskeletal 
conditions.
    PARAFON FORTE DSC (chlorzoxazone) tablets, 500 mg, is listed in the 
``Discontinued Drug Product List'' section of the Orange Book.
    Flamingo Pharmaceuticals Ltd. submitted a citizen petition dated 
November 7, 2015 (Docket No. FDA-2015-P-4224), under 21 CFR 10.30, 
requesting that the Agency determine whether PARAFON FORTE DSC 
(chlorzoxazone) tablets, 500 mg, were 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 PARAFON FORTE DSC (chlorzoxazone) tablets, 500 
mg, were not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
PARAFON FORTE DSC (chlorzoxazone) tablets, 500 mg, were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of PARAFON FORTE DSC 
(chlorzoxazone) tablets, 500 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 PARAFON FORTE DSC 
(chlorzoxazone) tablets, 500 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 PARAFON FORTE DSC (chlorzoxazone) 
tablets, 500 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 to 
meet current standards, the Agency will advise ANDA applicants to 
submit such labeling.

    Dated: July 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16635 Filed 7-13-16; 8:45 am]
BILLING CODE 4164-01-P