[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Page 63228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24781]
[[Page 63228]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0671]
Determination That PARAFLEX (Chlorzoxazone) Tablets, 250
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or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) has determined that
PARAFLEX (Chlorzoxazone) Tablets, 250 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withdrawn from sale for reasons of safety or effectiveness.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 PARAFLEX (Chlorzoxazone) Tablets, 250 mg, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Kathy Schreier, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6252, Silver Spring, MD 20993-0002, 301-
796-3432.
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drug was withdrawn from sale for reasons of safety or effectiveness (21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.
PARAFLEX (Chlorzoxazone) Tablets, 250 mg, is the subject of NDA 11-
300, held by Ortho McNeil Pharm, and was initially approved on December
12, 1958. PARAFLEX is indicated as an adjunct to rest, physical
therapy, and other measures for the relief of discomfort associated
with acute, painful musculoskeletal conditions.
In letters dated April 11, 1997, and April 22, 1997, a former NDA
holder, The R.W. Johnson Pharmaceutical Research Institute, notified
FDA that PARAFLEX (Chlorzoxazone) Tablets, 250 mg, had been
discontinued and requested withdrawal of NDA 11-300, and FDA moved the
drug product to the ``Discontinued Drug Product List'' section of the
Orange Book. In the Federal Register of September 25, 1997 (62 FR
50387), FDA announced that it was withdrawing approval of NDA 11-300,
effective September 25, 1997.
Lachman Consultant Services, Inc., submitted a citizen petition
dated June 4, 2013 (Docket No. FDA-2013-P-0671), under 21 CFR 10.30,
requesting that the Agency determine whether PARAFLEX (Chlorzoxazone)
Tablets, 250 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 PARAFLEX (Chlorzoxazone) Tablets, 250 mg, was
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that PARAFLEX
(Chlorzoxazone) Tablets, 250 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of PARAFLEX (Chlorzoxazone) Tablets, 250 mg,
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 product was withdrawn from
sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list PARAFLEX
(Chlorzoxazone) Tablets, 250 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 PARAFLEX (Chlorzoxazone) Tablets,
250 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: October 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24781 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P