CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 8-708/8023 Trade Name: Dibenzyline 10mg Generic Name: Phenoxybenzamine HCL Sponsor: Wellspring Pharmaceutical Corporation Approval Date: December 30, 2003 Indications: Indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta-blocking agent concomitantly.
Transcript
CENTER FOR DRUG EVALUATION AND RESEARCH
Approval Package for:
APPLICATION NUMBER:
8-708/8023
Trade Name: Dibenzyline 10mg
Generic Name: Phenoxybenzamine HCL
Sponsor: Wellspring Pharmaceutical Corporation
Approval Date: December 30, 2003
Indications: Indicated in the treatment of pheochromocytoma, tocontrol episodes of hypertension and sweating. Iftachycardia is excessive, it may be necessary to use abeta-blocking agent concomitantly.
CENTER FOR DRUG EVALUATION ANDRESEARCH
APPLICATION NUMBER:
8-708/8023
CONTENTS
i Reviews / Information Included in this NDA Review. ~
Approval Letter XApprovable LetterLabelin~ XSummary ReviewOfficer/E m ployeeListOffice Director MemoCross Discipline Team Leader ReviewMedical Review( s)Chemistry Review(s)
Environmental Assessment
Pharmacolo~y Review(s)Statistical Review(s)Microbiolo~y Review( s)Clinical Pharmacolo~y/Biopharmaceutics Review(s)Risk Assessment and Risk Mitigation Review(s)Proprietary Name Review(s)Other Review(s) XAdministrative/Correspondence Document(s) X
CENTER FOR DRUG EVALUATION ANDRESEARCH
APPLICATION NUMBER:
8-708/8023
APPROVAL LETTER
~ SE;RVIC'iS
(~' ~nEPARTMENT OF HEALTH & HUMAN SERVICES"::~~Public Health Service
Food and Drug AdministrationRockville, MD 20857
NDA S-70S/S-023
Wellspring Pharmaceutical CorporationAttention: Mr. Drew Karlan1430 Highway 34Neptune, NJ 07753-6S07
Dear Mr. Karlan:
Please refer to your supplemental new drug application dated August 29,2003, submitted under section 505(b)of the Federal Food, Drug, and Cosmetic Act for Dibenzyline (phenoxybenzamine HC!) 10 mg Capsules.
We acknowledge receipt of your submissions dated September 4 and November 14 and is, 2003.
This supplemental new drug application provides for draft labeling revised to remove the following statementsfrom the container label:
Warning: Potent drug- Not to be used except under close supervision of a physician.
Important: Use safety closures when dispensing this product unless otherwise directed by physician orrequested by purchaser.
We have completed our review of this application, as amended. This application is approved, effective on thedate of this letter, for use as recommended in the agreed-upon labeling text.
The final printed labeling (FPL) must be identical to the submitted labeling dated November is, 2003.
Please submit the FPL electronically according to the guidance for industry titled Providing RegulatorySubmissions in Electronic Format ~ NDA. Alternatively, you may submit 20 paper copies of the FPL as soon asit is available, in no case more than 30 days after it is printed. Please individually mount 15 of the copies onheavy-weight paper or similar materiaL. For administrative purposes, this submission should be designated "FPLfor approved supplement NDA S-70S/S-023." Approval of this submission by FDA is not required before thelabeling is used.
If you issue a letter communicating important information about this drug product (i.e., a "Dear Health CareProfessional" letter), we request that you submit a copy of the letter to this NDA and a copy to the followingaddress:
We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 31 4.S0 and314.S1).
If you have any questions, please call:
NDA 8-708/S-023Page 2
Ms. Melissa RobbRegulatory Project Manager
(301) 594-5313
Sincerely,
Douglas C. Throckmorton, M.D.DirectorDivision of Cardio-Renal Drug ProductsOffce of Drug Evaluation ICenter for Drug Evaluation and Research
..._--------------------------------------------------_._----_._--------------_._----~-------_._--------_..-._----...This is a representation of an electronic record that was signed electronically andthis page is the manifestation of the electronic signature.------------._-------------------------------------------------------------------------------------------------------/s/
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Evaluation:This submission provides for draft labeling revised to remove the following statements from the containerlabel as they are common sense and have become standard of care:
Warning: Potent drug- Not to be used except under close supervision of a physician.
Important: Use safety closures when dispensing this product unless otherwise directed byphysician or requested by purchaser.
Recommendation:An approval on draft letter should be issued for this supplement as set forth under 21 CFR 314.70 (b) (3)(Any change in labeling).
Melissa Robb, RHPM
I
i
This is a representation of an, electronic record that was signed electronically andthis page is the manifestation of the electronic signature.
/s/Melissa Robbi 2/3 a / a 3 03: 46 : a 9 PMCSO
RHPM Review of Final Printed LabelingNDA 8-708/S-023
Date of Submission:Date of Review:Applicant Name:Product Name:
September 22,2004June 6,2005Wellspring Pharmaceutical CorporationDibenzy1ine (phenoxybenzamine HCl) 10 mg Capsules
Evaluation:This submission includes the final printed container labeling in response to the approval on draft letterissued for this supplement dated December 30,2003.
The following statements were removed from the label as noted in the approval on draft letter:
Warning: Potent drug- Not to be used except under close supervision of a physician.
Important: Use safety closures when dispensing this product unless otherwise directed byphysician or requested by purchaser.
In addition, the following changes were also noted on the container label:
1. The manufacturing information was changed from:
Per Dr. Srinivasachar, both of these changes are acceptable. The change in manufacturing site wasapproved in S-024.
Recommendation:An aclmowledge and retain letter should be issued for this supplement.
Melissa Robb, RHM
This is a representation of an electronic record that was signed electronically andthis page is the manifestation of the electronic signature.------------------------------------------------------------------------------_._----_.._--------------------------_./s/
Melissa Robb6/22/05 10:38:57 AMCSO
CENTER FOR DRUG EVALUATION ANDRESEARCH
APPLICATION NUMBER:
8-708/8023
ADMINISTRATIVE and CORRESPONDENCEDOCUMENTS
..",,,~,~ sERV'~
~ J#~";:::lit
DEP ARTMENT OF HEALTH & HUMAN SERVICES Public Health SeNice
Food and Drug AdministrationRockville, MD 20857
NDA 8-708/S-023
WellSpring Pharmaceutical CorporationAttention: Mr. Drew Karlan1430 Highway 34Neptune, NJ 07753-6807
Dear Mr. Karlan:
We have received your supplemental drug application submitted under section 505(b) of theFederal Food, Drug, and Cosmetic Act for the following:
Name of Drug Product: DibenzylinecI (phenoxybenzamine hydrochloride) 10 mg Capsules
NDA Number: 8-708
Supplement number: 023
Date of supplement: August 29, 2003
Date of receipt: September 3, 2003
This supplemental application proposes to remove the following statements from the packageinsert:
. "Warning: Potent drug ~ not to be used except under the close supervision of a physician."
. "Important: Use safety closure when dispensing this product unless otherwise directed by
physician or requested by purchaser."
Unless we notify you within 60 days of the receipt date that the application is not sufficientlycomplete to permit a substantive review, we wil fie the application on November 2,2003, inaccordance with 21 CFR 314.101(a).
NDA 8-708/S-023Page 2
All communications concerning this supplement should be addressed as follows:
U.S. Postal Service:
Food and Drug AdministrationCenter for Drug Evaluation and ResearchDivision of Cardio-Renal Drug Products, HFD-11 0Attention: Division Document Room, 50025600 Fishers LaneRockvile, Maryland 20857
Courier/Overnight Mail:
Food and Drug AdministrationCenter for Drug Evaluation and ResearchDivision ofCardio-Renal Drug Products, HFD-110Attention: Division Document Room, 50021451 Rockvile PikeRockville, Maryland 20852
If you have any questions, please call:
Ms. Melissa RobbRegulatory Health Project Manager(301) 594-5313
Sincerely,
Zelda McDonaldChief, Project Management StaffDivision of Cardio-Renal Drug ProductsOffce of Drug Evaluation ICenter for Drug Evaluation and Research
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Zelda McDonald9/9/03 11:00:31 AM
(-~ DEPARTMENT OF HEAL TH & HUMAN SERVICES',,~::~t- Public Health Service
We acknowledge receipt of your September 22,2004 submission containing final printed labeling in response to ourDecember 30, 2003 letter approving your supplemental new drug application for Dibenzyline (phenoxybenzaminehydrochloride) 10 mg Capsules.
We have reviewed the container labeling that you submitted in accordance with our December 30, 2003 letter andwe find it acceptable.
If you have any questions, please call:
Ms. Melissa RobbRegulatory Health Project Manager(301) 594-5313
Sincerely,
Norman Stockbridge, M.D., Ph.D.Acting DirectorDivision ofCardio-Renal Drug ProductsOffice of Drug Evaluation ICenter for Drug Evaluation and Research
This is a representation of an electronic record that was signed electronically andthis page is the manifestation of the electronic signature.
