NDA 022331_Clonodine HCl_Approval Letter

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Silver Spring MD 20993
NDA 022331 NDA APPROVAL
Addrenex Pharmaceuticals, Inc.

Attention: Moise A. Khayrallah, Ph.D.
President & CEO
4825 Creekstone Drive, Suite 100
Durham, NC 27703
Dear Dr. Khayrallah:
Please refer to your new drug application (NDA) dated February 15, 2008, received February 19, 2008,
submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, for Jenloga
(clonidine hydrochloride) tablets 0.1 mg.
We acknowledge receipt of your submissions dated March 27, May 21, July 27, and August 14, 2009.
The March 27, 2009, submission constituted a complete response to our December 19, 2008, action letter.
This new drug application provides for the use of Jenloga (clonidine hydrochloride) tablets for the
treatment of hypertension.
We have completed our review of this application, as amended. It is approved, effective on the date of
this letter, for use as recommended in the enclosed agreed-upon labeling text.
DISSOLUTION SPECIFICATIONS
We note that the following dissolution specifications were agreed-upon during a September 23, 2009,
teleconference between representatives from the Agency and Addrenex:
Time (hours) % Released

1 (b)
(4)
(b)
4
(4)
(b)
8
(4)
(b)
16
(4)
CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, please submit the content of
labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is identical
to the enclosed labeling. For administrative purposes, please designate this submission, “SPL for
approved NDA 022331.”
NDA 022331 Page 2
CARTON AND IMMEDIATE CONTAINER LABELS

Submit final printed carton and container labels that are identical to the enclosed immediate container
labels as soon as they are available, but no more than 30 days after they are printed. Please submit these
labels electronically according to the guidance for industry titled Providing Regulatory Submissions in
Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications (October 2005). Alternatively, you may submit 12 paper copies, with 6 of the copies
individually mounted on heavy-weight paper or similar material. For administrative purposes, designate
this submission “Final Printed Carton and Container Labels for approved NDA 022331.” Approval
of this submission by FDA is not required before the labeling is used.
Marketing the product with FPL that is not identical to the approved labeling text may render the product
misbranded and an unapproved new drug.
REQUIRED PEDIATRIC ASSESSMENTS

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active
ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are
required to contain an assessment of the safety and effectiveness of the product for the claimed
indication(s) in pediatric patients unless this requirement is waived, deferred, or inapplicable.
We are waiving the pediatric study requirement for ages 0 to 5 years because the product does not
represent a meaningful therapeutic benefit over existing therapies for pediatric patients in this age group
and is not likely to be used in a substantial number of pediatric patients in this group.
We are deferring submission of your pediatric study for ages 6 to 17 years for this application because
this product is ready for approval for use in adults and the pediatric study have not been completed.
Your deferred pediatric study required by section 505B(a) of the Federal Food, Drug, and Cosmetic Act
are a required postmarketing study. The status of this postmarketing study must be reported annually
according to 21 CFR 314.81 and section 505B(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act.
This required study is listed below.
1. Deferred pediatric study under PREA for the treatment of hypertension in pediatric patients ages
6 to 17.
Final Report Submission: December 2012
Submit final study reports to this NDA. For administrative purposes, all submissions related to this
required pediatric postmarketing study must be clearly designated “Required Pediatric Assessment.”
PROMOTIONAL MATERIALS
In addition, we request that you submit one copy of the introductory promotional materials you propose to
use for this product to this division.
LETTERS TO HEALTH CARE PROFESSIONALS

If you issue a letter communicating important safety-related information about this drug product (i.e., a
“Dear Health Care Professional” letter), we request that you submit an electronic copy of the letter to both
this NDA and to the following address:
NDA 022331 Page 3
MedWatch
Food and Drug Administration
Suite 12B-05
5600 Fishers Lane
Rockville, MD 20857
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80
and 314.81).
If you have any questions, please call Russell Fortney, Regulatory Project Manager, at (301) 796-1068.
Sincerely,
{See appended electronic signature page}
Norman Stockbridge, M.D., Ph.D.

Director
Division of Cardiovascular and Renal Products
Office of Drug Evaluation I
Center for Drug Evaluation and Research
Enclosures: Agreed-upon labeling text and container labels

Application Submission Submitter Name Product Name
Type/Number Type/Number
-------------------- -------------------- -------------------- ------------------------------------------
NDA-22331 ORIG-1 ADDRENEX JENLOGA
PHARMACEUTICA
LS INC
---------------------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
---------------------------------------------------------------------------------------------------------
/s/
----------------------------------------------------
NORMAN L STOCKBRIDGE
09/29/2009

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

NDA 022331 NDA APPROVAL

Addrenex Pharmaceuticals, Inc.

Dear Dr. Khayrallah:

Time (hours) % Released

CARTON AND IMMEDIATE CONTAINER LABELS

REQUIRED PEDIATRIC ASSESSMENTS

Final Report Submission: December 2012

LETTERS TO HEALTH CARE PROFESSIONALS

{See appended electronic signature page}

Norman Stockbridge, M.D., Ph.D.

Enclosures: Agreed-upon labeling text and container labels

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