[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7582-7583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3222]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0291]


Determination That JENLOGA (Clonidine Hydrochloride) Extended-
Release Tablets, 0.1 Milligram and 0.2 Milligram, Were Not Withdrawn 
From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined that 
JENLOGA (clonidine hydrochloride) Extended-Release Tablets, 0.1 
milligram (mg) and 0.2 mg, were not withdrawn from sale for reasons of 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, 0.1 mg and 0.2 mg, if all other requirements 
are met.

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 approved 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,''

[[Page 7583]]

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.
    JENLOGA (clonidine hydrochloride) Extended-Release Tablets, 0.1 mg 
and 0.2 mg, are the subject of NDA 22-331, held by Shionogi Pharma, 
Inc., initially approved on September 29, 2009. JENLOGA is indicated 
for the treatment of hypertension. Shionogi Pharma has never marketed 
JENLOGA (clonidine hydrochloride) Extended-Release Tablets, 0.1 mg and 
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-0291), under 21 CFR 10.30, requesting that the 
Agency determine whether JENLOGA (clonidine hydrochloride) Extended-
Release Tablets, 0.1 mg and 0.2 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 JENLOGA (clonidine hydrochloride) Extended-
Release Tablets, 0.1 mg and 0.2 mg, were not withdrawn from sale for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that JENLOGA (clonidine 
hydrochloride) Extended-Release Tablets, 0.1 mg and 0.2 mg, were 
withdrawn from sale for reasons of safety or effectiveness. We have 
carefully reviewed our files for records concerning the withdrawal of 
JENLOGA (clonidine hydrochloride) Extended-Release Tablets, 0.1 mg and 
0.2 mg, from sale. We have found no information that would indicate 
that these products were withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, FDA will continue to list JENLOGA (clonidine 
hydrochloride) Extended-Release Tablets, 0.1 mg and 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 JENLOGA (clonidine 
hydrochloride) Extended-Release Tablets, 0.1 mg and 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. 2012-3222 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P