[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7581-7582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3223]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0292]


Determination That KAPVAY (Clonidine Hydrochloride) Extended-
Release Tablets, 0.2 Milligram, Was Not Withdrawn From Sale for Reasons 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 
KAPVAY (clonidine hydrochloride) Extended-Release Tablets, 0.2 
milligram (mg), was not withdrawn from sale for reasons of safety or 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 clonidine hydrochloride extended-
release tablets, 0.2 mg, if all other requirements are met.

[[Page 7582]]


FOR FURTHER INFORMATION CONTACT:  Kristiana Brugger, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6262, Silver Spring, MD 20993-0002, 301-
796-3601.

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 only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    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.
    KAPVAY (clonidine hydrochloride) Extended-Release Tablets, 0.2 mg, 
is the subject of NDA 22-331, held by Shionogi Pharma, Inc., and 
initially approved on September 28, 2010. KAPVAY is indicated for the 
treatment of attention deficit hyperactivity disorder as monotherapy or 
as adjunctive therapy to stimulant medications. Shionogi Pharma has 
never marketed KAPVAY (clonidine hydrochloride) Extended-Release 
Tablets, 0.2 mg. In previous instances (see, e.g., 72 FR 9763, March 5, 
2007; 61 FR 25497, May 21, 1996), the Agency has determined that, for 
purposes of Sec. Sec.  314.161 and 314.162, never marketing an approved 
drug product is equivalent to withdrawing the drug from sale.
    Actavis, Inc. submitted a citizen petition dated April 20, 2011 
(Docket No. FDA-2011-P-0292), under 21 CFR 10.30, requesting that the 
Agency determine whether KAPVAY (clonidine hydrochloride) Extended-
Release Tablets, 0.2 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 KAPVAY (clonidine hydrochloride) 
Extended-Release Tablets, 0.2 mg, was not withdrawn from sale for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that KAPVAY (clonidine 
hydrochloride) Extended-Release Tablets, 0.2 mg, was withdrawn from 
sale for reasons of safety or effectiveness. We have carefully reviewed 
our files for records concerning the withdrawal of KAPVAY (clonidine 
hydrochloride) Extended-Release Tablets, 0.2 mg from sale. We have 
found no information that would indicate that this product was 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, FDA will continue to list KAPVAY (clonidine 
hydrochloride) Extended-Release Tablets, 0.2 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 KAPVAY (clonidine hydrochloride) 
Extended-Release Tablets, 0.2 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: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3223 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P