CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-030
`
`OTHER REVIEWgS}
`
`

`

`Department of Health and Human Services
`Public Health Service
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
` October 14, 2008
`
`To:
`
`Scott Monroe, M.D., Director
`
`Division of Reproductive & Urologic Products
`
`Through:
`
`Jodi Duckhorn, M.A. Team Leader
`
`Patient Labeling and Education Team
`
`Division of Risk Management
`
`' From?
`
`Nancy Carothers, BA, RN
`
`Patient Product Information Specialist
`
`Patient Labeling and Education Team
`
`Division of Risk Management
`
`Subject:
`
`Review of Patient Labeling for TOVIAZTM (Patient Package
`Insert), #2
`
`Drug Name(s):
`
`TOVIAZTM (fesoterodine furnarate, extended release tablets)
`
`Application Type/Number: NDA 22~030
`
`Applicant/sponsor:
`
`Pfizer
`
`OSE RCM #:
`
`2008-810
`
`

`

`RESPONSE TO SPONSOR’S REVISIONS TO THE PPI:
`
`Please see our response the sponsor’s revision of the TOVIAZ PPI:
`
`1.
`
`If the sponsorW we recommend the term
`“doctor.” One term should be used consistently throughout the PPI. we recommend
`against the term “healthcare professional” as it is not generally understood.
`
`2. We defer to the Review Division on the question of whether TOVLAZ inhibits or induces
`enzymes involved in the metabolism of other drugs.
`
`[doctor] may give you a
`3. We recommend retaining the bullet, ’TM—%—~%
`lower dose if you have certain medical conditions such as severe kidney problems.” The
`PI states in three sections (Phamacokinetics in Special Populations, Dosage and
`Administration, and Precautions) that TOVIAZ is not recommended for patients with
`severe renal insufficiency at doses higher than 4 mg. This bullet provides additional
`safety information concerning the patient’s medical condition (severe renal insufficiency)
`and the recommended dosing of TOVIAZ. It is important for these patients to understand
`clearly that a higher dose is not recommended, especially if their renal problems change
`from less serious to more serious during their course of treatment with TOVIAZ.
`/
`
`a
`
`
`
`7
`
`5. We agree with listing “constipation” as one of the most common side effects.
`
`
`7. The statement, “Safely throw away TOVIAZ that is out of date or no longer needed”
`:
`.2)
`Again, we
`generally recommend following the Medication Guide regulations as much as possible
`for consistency across all patient labeling.
`
`MATERIAL REVIEWED FOR THIS RESPONSE:
`
`0
`
`I
`
`TOVIAZTM PI submitted by the Sponsor on May I, 2008 and further revised by the
`reviewing division on September 4, 2008
`
`TOVIAZTM PPI submitted by the Sponsor on May 1, 2008 and further revised by
`the reviewing division on September 9, 2008
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Nancy B Carothers
`10/14/2008 02:36:42 PM
`DRUG SAFETY OFFICE REVIEWER
`
`Jodi Duckhorn
`10/14/2008 03:05:40 PM
`DRUG SAFETY OFFICE REVIEWER
`
`

`

` 5°" ‘ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
`
`[VIC
`¥“ 5‘
`53.0:
`
`
`E
`é
`“6"
`””3
`
`(
`
`.
`Pediatric and Maternal Health Staff
`Office of New Drugs
`Center for Drug Evaluation and Research
`Food and Drug Administration
`Silver Spring, MD 20993
`Tel 301—796-0700
`FAX 301-796-9744
`
`Maternal Health Team Review
`
`Date:
`
`September 8, 2008
`
`-
`
`Date Consulted: June 27, 2008
`
`From:
`‘
`
`Richardae Araojo, Pharm.D.
`Regulatory Reviewer, Maternal Health Team (MHT)
`Pediatric and Maternal Health Staff
`
`Tammie Brent, RN, MSN
`Regulatory Reviewer, Maternal Health Team (MHT)
`Pediatric and Maternal Health Staff
`
`Through:
`
`Karen Feibus, MD
`Team Leader, Maternal Health Team (MHT)
`Pediatric and Maternal Health Staff
`
`Lisa Mathis, MD
`Associate Director, Pediatric and Maternal Health Staff
`
`To:
`
`Division of Reproductive and Urologic Products (DRUP)
`
`Drug:
`
`Toviaz (fesoterodine fumarate) tablets; NDA 22—030
`
`Subject:
`
`Pregnancy and Nursing Mothers labeling
`
`Materials
`
`Reviewed:
`
`Pregnancy and Nursing Mothers subsections of Toviaz labeling.
`
`Consult
`
`Question:
`
`This request is for a labeling consult for NDA 22-030. Please review the
`Pregnancy and Nursing Mothers subsections of labeling.
`
`

`

`INTRODUCTION
`
`On January 25, 2007, the Division of Reproductive and Urologic Products (DRUP) issued an
`approvable letter to Schwarz Bioscience, a manufacturer for Pfizer Global Pharmaceuticals, for
`their new drug application (NDA) 22—030 for Toviaz (fesoterodine furnarate). On May 2, 2008,
`Pfizer Global Pharmaceuticals submitted a complete response to the approvable letter for NDA
`22-030 to DRUP. The sponsors proposed indication for Toviaz is for the treatment of overactive
`bladder with symptoms of urge urinary incontinence, urgency, and frequency.
`On June 27, 2008,-DRUP consulted the Maternal Health Team (MHT) to review and revise the
`. pregnancy and nursing mothers section of the Toviaz package insert. This review provides
`revisions to the sponsors proposed Pregnancy and Nursing Mothers subsections of Toviaz
`labeling.
`
`BACKGROUND
`
`The Maternal Health Team (MHT) is working to develop a more consistent and clinically usefial
`approach to the Pregnancy and Nursing Mothers subsections of labeling. This approach
`_
`complies with current regulations but incorporates “the spirit” of the Proposed Pregnancy and
`Lactation Labeling Rule (published on May 28, 2008).
`
`As part of the labeling review, the MHT reviewer conducts a literature search to determine if
`relevant published pregnancy and lactation data are available that would add clinically useful
`information to the pregnancy and nursing mothers label subsections. In addition, the MHT
`presents available animal data, in the pregnancy subsection, in an organized, logical format that
`makes it as clinically relevant as possible for prescribers. This includes expressing animal data
`in terms of species exposed, timing and route of drug administration, dose expressed in terms of
`human dose equivalents (with the basis for calculation), and outcomes for dams and offspring.
`For nursing mothers, when animal data are available, only the presence or absence of drug in
`milk is considered relevant and presented in the label, not the amount.
`
`This review provides revisions to the sponsors proposed Pregnancy and Nursing Mothers
`subsections of Toviaz labeling. The revisions are provided in both non-PLR format and in PLR
`format.
`
`SUMBMITTED MATERIAL
`
`Sponsors Proposed Pregnancy and Nursing Mothers Labeling
`
`Pregnancy
`Pregnancy Category C
`
`Q
`
`2. W
`
`"nun.
`
`I .1 Allbllnblvwl \v av _. nun.--” "A- VA-rvvv-‘o .u-rvvwv w— w..- -._....-.. 7..--.. -__. __v ., _...__
`
`

`

`Nursing Mothers
`
`RECOMMENDATIONS
`
`Provided below are the MHT’s recommended revisions to the sponsors’ proposed labeling. The
`recormnendations are provided in non-PLR format and in PLR format. Additionally, MHT
`requested the phannacology/toxicology team calculate the correct multiple of human exposure
`based on AUC at MRHD for the mouse dose of 30 mg/kg/day (see attached label for comment).
`Appendix A of this review provides a track changes version of labeling that highlights all
`changes made.
`
`1) Non-PLR Format:
`
`Pregnancy
`Pregnancy Category C
`
`M4)
`
`M4}
`
`

`

`91+ Page(s) Withheld
`
`‘ _* g 55-2(b)(4) Trade secret/Confidential
`
`4 § 552(b)(4) Draft Labeling .
`
`'
`
`:
`
`§ 552(b)_(‘5)'Deliberative Process
`
`

`

`CONCLUSIONS
`
`While the Proposed Pregnancy and Lactation Labeling Rule, published May 2008, is in the
`clearance process, the MHT is structuring the Pregnancy and Nursing Mothers label information
`in a way that is in the spirit of the Proposed Rule while still complying with current regulations.
`The goal of this restructuring is to make the pregnancy and lactation sections of labeling a more
`effective communication tool for clinicians.
`'
`
`The MHT’s recommended labeling for Toviaz is provided on pages 3-5 of this review.
`Appendix A of this review also provides a track changes version of labeling.
`
`.
`Appendix A —
`Track Changes Version of Labeling
`
`Appears This Way
`On Original
`
`

`

`A _a[_ Page(s) Withheld
`
`___§ 552(b)(4) Trade Secret / Confidential
`
`E § 552(b)(4) Draft Labeling
`__ § 552(b)_(5)'DeliberatiVe Process
`
`C (2 Wet Reuieu
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Tammie Brent—Steele
`9/12/2008 01:53:41 PM
`CSO
`
`Chardae Araojo
`9/15/2008 09:02:53 AM
`CSO
`
`Karen Feibus
`9/16/2008 05:01:41 PM
`MEDICAL OFFICER
`
`Lisa Mathis
`9/18/2008 09:07:57 PM
`MEDICAL OFFICER
`
`

`

`Department of Health and Human Services
`
`Public Health Service
`
` Office of Surveillance and Epidemiology
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`:Date:
`
`To:
`
`Through:
`
`September 10, 2008
`
`Scott Monroe, M.D., Director
`
`Division of Reproductive & Urologic Products
`
`Jodi Duckhorn, M.A. Team Leader
`Patient Labeling and Education Team
`Division of Risk Management
`
`From:
`
`Nancy Carothers, BA, RN
`
`Patient Product Information Specialist
`
`Patient Labeling and Education Team
`Division of Risk Management
`
`Subject:
`
`Review of Patient Labeling for TOVIAZTM (Patient
`Package Insert)
`
`Drug Name(s):
`
`TOVIAZT'“ (fesoterodine fumarate, extended release
`tablets)
`
`Application
`Type/Number:
`
`NDA 22-030
`
`Applicant/sponsor:
`
`Pfizer
`
`OSE RCM #:
`
`2008-810
`
`

`

`INTRODUCTION
`
`On May 1, 2008, the sponsor submitted a Complete Response, to FDA’s “Approvable letter”
`sent to the sponsor on January 25, 2007. The Complete Response included revisions to the
`Professional Information (PI), Patient Package Insert (PPI), and packaging; along with
`clinical pharmacology and clinical study updates as requested by FDA. ThePPI was
`updated from a version submitted with the original NDA on March 16, 2006. The revised
`PPI contains the new trade name, TOVIAZ, and other editorial changes, and is presented in
`the FDA recommended question—and~answer format.
`
`The Division of Reproductive and Urologic Products requested that the Patient Labeling and
`Education Team review the Patient Package Insert (PPI) for this product. This review is
`written in response to that request.
`
`MATERIAL REVIEWED
`
`o TOVIAZTM PI submitted by the Sponsor on May 1, 2008 and further revised by the
`reviewing division on September 4, 2008
`o TOVIAZTM PPI submitted by the Sponsor on May 1, 2008 and further revised by
`the reviewing division on September 9, 2008
`
`DISCUSSION
`
`The purpose of patient labeling is to enhance appropriate use of and to provide important risk
`information about medicines. Our recommended changes are consistent with current research to
`improve risk communication to a broad audience, including those with lower literacy.
`
`The PPI submitted by the sponsor has a Flesch Kinkaid grade level of 7.6, and a Flesch Reading
`Ease score of 59.1 %. To enhance patient comprehension, materials should be written at a 6th to
`8th grade reading level, and have a reading ease score of at least 60% (60% corresponds to an 8"1
`grade reading level).
`In our review of the PPI, We have:
`
`0
`
`simplified the wording and clarified concepts where possible,
`
`0 made the information in the PPI consistent with the PI,
`
`0
`
`removed unnecessary and redundant information from the PPI,
`
`o
`
`ensured that the PPI meets the criteria as specified in FDA’s Guidance for Useful
`Written Consumer Medication Information (published July 2006).
`In 2008, The American Society of Consultant Pharmacists Foundation in collaboration with The.
`American Foundation for the Blind published Guidelinesfor Prescription Labeling and Consumer
`Medication Informationfor People with Vision Loss. They recommend using fonts such as Arial,
`Verdana, or APHont to make medical information more accessible for patients with low vision. We
`have reformatted the PPI document using the font APHont, which was developed by the American
`Printing House for the Blind specifically for low vision readers.
`
`

`

`See the attached document for our recommended revisions to the PP]. Comments to the review
`
`division are bolderl, underlined, and italicized.
`
`We are providing to the review division a marked-up and clean copy of the revised PP].
`
`4
`
`CONCLUSIONSAND’RECOMMENDATIONS
`
`11(4)
`
`The PI says in the Informationfor Patients section that alcohol may enhance the drowsiness caused
`by anticholinergic agents, such as TOVIAZ.W
`
`Wm!”
`The Precautions, Drug—Drug Interactions, and Dosage and Administration sections of the PI,
`state that an interaction with potent CYP3A4 inhibitors may occur when using TOVIAZ
`doses greater than 4 mg daily. Patients should be told to tell their healthcare provider,
`specifically, if they are taking antibiotics or antifimgal medicines. A patient’s infectious
`condition may not be related to overactive bladder and, as a result, may not be apparent to the
`prescribing healthcare provider.
`In the How should I take T0VIAZ7 section of the PPI, add information on taking a lower
`dose for patients with severe kidney problems, and instructions on what to do if a dose15
`missed or for an overdose.
`
`The activities for patients to avoid: 1) use of alcohol that can increase drowsiness, 2) a heated or
`warm environment that can cause heat prostration (due to decreased sweating), and blurred vision
`
`appear in the Informationfor Patients section of the PI
`
`M These actiVities should be added to the ’
`r--——-—’ section o'fthe PPI.
`
`‘
`
`C.
`
`\
`
`W/
`
`Under the section On the possible side effects, we added the following information:
`Call yourdoctor for medical advice about side effects. You may report side effects to the FDA at 1-
`800-FDA- 1088.
`-'
`
`This verbatim statement is required for all Medication Guides effective January 2008 (see 21
`CFR 208.20 (b)(7)(iii); also see Interim Final Rule, Toll-Free Number for Reporting Adverse
`events on Labeling for Human Drug Products in Federal Register Vol. 73, No.2, p.402-404,
`1/3/2008). Although not required for voluntary PPIs, like TOVIAZ, we recommend adding this
`language to all' FDA—approved patient labeling for consistency.
`
`11(4)
`
`

`

`.
`
`Patients should be advised on the safe disposal of their medicines and this should be added to the
`section, How should I store TOVIAZ? Some formulations cannot be thrown away and should not be
`flushed, according to the White House and EPA recommendations. This information should be added
`to the PI for consistency.
`
`- The sponsor uses both the terms "doctor" ‘——\——-——————-——————————-———~—-
`W We recommend that one term be used consistently throughout
`the PPI.
`
`Please let us know if you have any questions.
`
`Appears This Way
`On Original
`
`

`

`i Page(s) Withheld
`
`__
`
`.
`
` § 552(b)(4) Trade SECI‘E’C/ Confidential
`
`_'_><__ § 552(b)(4) Draft Labeling _
`
`_ __ § 552(b)(5)Deliberative Process
`
`I
`
`, 3 (QM/Lew %Q\/ (ea):
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`--------------------—------------------------—-----.-------------------unn-n--n-____-__—--—--—-_---_--__.--—------—-
`
`Nancy B Carothers
`9/10/2008 04:21:59 PM.
`DRUG SAFETY OFFICE REVIEWER
`
`Jodi Duckhorn
`9/10/2008 O4t25z49 PM
`DRUG SAFETY OFFICE REVIEWER
`
`

`

`MEMORANDUM
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`
`Pre-decisional Agency Information
`
`
`Date:
`
`.
`
`July 25, 2008
`
`From:
`
`Elaine Hu Cunningham, DDMAC
`Aline Moukhtara, DDMAC
`
`To:
`
`Celia Hayes, DRUDP
`
`Re:
`
`ToviazW' (fesoterodine fumarate) extended-release tablets
`NDA 22-030
`
`
`DDMAC comments are provided on draft PI, PPl, and carton labeling submitted by Pfizer on May
`2, 2008 for ToviazTM (fesoterodine fumarate) extended-release tablets.
`
`DRAFT PI DATED APRIL 22 2008:
`
`DESCRIPTION
`
`Fesoterodine is rapidly de-esterified to its active metabolite... (emphasis added)
`
`The descriptor, “rapidly,” is promotional in nature and may be used in promotional
`materials to imply superiority or overstate the efficacy of Toviaz compared to its
`competitors. Please consider deleting this descriptor to be consistent with competitors’
`labeling information.
`
`CLINICAL PHARMACOLOGY
`
`SI
`
`

`

` __§__ Page(s) Withheld
`
`.
`
`a
`
`'
`
`‘
`
`l § 552(b)(4) Trade Secret/ Confidential
`
`__L § 552(b)(4) Draft Labeling
`
`_‘___ § 552(b)(5) Deliberative Process
`
`9’ MW flea/8w.
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Elaine J. Hu
`
`7/25/2008 03:31:19 PM
`DDMAC REVIEWER
`
`

`

`MEMORANDUM
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`PUBLIC HEALTH SERVICE
`
`FOOD AND DRUG ADMINISTRATION
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`DATE:
`
`July 31, 2006
`
`TO:
`
`Daniel Shames, MD. Director
`
`Division of Reproductive and Urologic Drug Products
`
`VIA:
`
`FROM:
`
`Jean Makie, Regulatory Health Project Manager
`
`Division of Reproductive and Urologic Drug Products
`
`Sharon R. Mills, B.S.N., R.N., C.C.R.P. ,
`
`Patient Product Information Specialist
`
`Division of Surveillance, Research, and Communication Support
`
`THROUGH:
`
`Toni Piazza-Hepp, Pharm.D., Deputy Director
`
`Division of Surveillance, Research, and Communication Support
`
`SUBJECT:
`
`DSRCS Review of Patient Labeling for TRADENAME (fesoterodine
`fumarate), NDA 22-030.
`
`See the attached Patient Package Insert (PPI) for our recommended revisions to the proposed
`patient labeling for TRADENAME (fesoteridone fumarate) 4 mg and 8 mg extended—release
`tablets, NDA 22-030. The purpose of patient information leaflets is to enhance appropriate use
`and provide important risk information about medications. We have simplified the wording
`where possible, made it consistent with the Professional Labeling (PI) and removed unnecessary
`information. We have also put this PPI in the patient-friendly format (specified in 21 CFR
`208.20) that we are recommending for all FDA approved patient labeling, although this format is
`not required for voluntary PPIs. These recommended changes are consistent with research to
`improve risk communication to a lower literacy audience.
`
`Page 1
`
`

`

`These revisions are based on proposed professional labeling (PI) submitted on March 17, 2006
`f0r this new molecular entity. Patient information should always be consistent with the
`prescribing information. All future relevant changes to the PI should also be reflected in the PPI.
`
`Comments and Recommendations
`
`1. A PPI for TRADENAME (fesoterodine fiimarate) is voluntary. Except where drug .
`products are dispensed in unit-of-use packaging with the PPI enclosed, it is highly
`unlikely that patients will receive the APPI. According to the PI, TRADENAME
`(fesoterodine furnarate) will be supplied in bottles of 30 and 90 tablets. The sponsor
`should state their mechanism for intended distribution of the PPI to patients.
`2. The sponsor uses the terms “doctor” w. in the proposed PPI. The
`patient may be confused about who they should talk to. We recommend that you use one
`term consistently throughout the PPI.
`3. Heat prostration is a possible adverse event that can occur in patients taking
`TRADENAME (fesoterodine femarate) and other OABs as well as other anticholinergic
`drugs. It is in the PI but is not reflected in the draft PPI submitted by the sponsor. We
`r
`have added language fM
`- - _hm Patients
`
`M4)
`
`taking TRADENAME (fesoterodine fumarate) should be made aware that they may
`become overheated and why, as well as what action(s) to take.
`
`M4)
`
`Comments to the review division are bolded, underlined and italicized. We are providing a
`marked-up and clean copy of the revised PPI attached to this memo as well as separate electronic
`word files.
`'
`
`Please call us if you have any questions.
`
`Page 2
`
`

`

`.
`
`E ~ Page(s) Withheld
`
`§ 552(b)(4) Trade Secret /'C0nfidentia1
`
`%
`
`§ 552(b)(4) Draft Labeling '
`
`' __ § 552(b)(5) Deliberative Process
`
`A
`
`. 5 OWN Rem'ews
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`/S/
`
`Sharon Mills
`7/31/2006 09:52:54 AM
`DRUG SAFETY OFFICE REVIEWER
`
`Toni Piaz za Hepp
`7/31/2006 05:53:51 PM
`DRUG SAFETY OFFICE REVIEWER
`
`

`

`
`
`DIVISION OF NIEDICATION ERRORS AND TECHNICAL SUPPORT
`OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY
`
`(DMETS; W0: 22, Mailstop 4447)
`
`CONSULTATION RESPONSE
`
`DATE RECEIVED:
`
`DESIRED COMPLETION DATE: OSE REVIEW #: 05-0071-2
`
`May 15, 2006
`DOCUMENT DATE:
`March 17, 2006
`
`August 15, 2006 _
`PDUFA DATE: January 27, 2007
`
`Daniel Shames, MD.
`Director, Division of Reproductive and Urologic Products
`HFD—S 80
`
`NDA#: 22-030 (IND# 5 1,232) NDA SPONSOR: Schwarz Pharma
`
`THROUGH: Alina Mahmud, RPh., MS, Team Leader
`Denise Toyer, PharmD., Deputy Director
`Carol Holquist, RPh., Director
`Division of Medication Errors and Technical Support, HFD-420
`
`Linda Wisniewski, RN, Safety Evaluator
`Division of Medication Errors and Technical Sup v ort, HFD—420
`PRODUCT NAME:
`Fesoteridine Fumarate Extended-release Tablets
`
`' 4 mg and 8 mg
`
`SAFETY ~EVALUATOR: Linda M. Wisniewski, RN
`RECOMMENDATIONS:
`
` DMETS recommends implementation of the label and labeling revisions outlined in section II of this review
`
`
`to minimize potential errors with the use of this product.
`
`
`
`DMETS would appreciate feedback of the final outcome of this consult. Wewould be willing to meet with
`the Division for further discussion, if needed. If you have further questions or need clarifications, please
`
`
`contact Diane Smith, Project Mana - er, at 301-796-0538.
`
`
`
`

`

`Division of Medication Errors and Technical Support (DMETS)
`Office of Surveillance and Epidemiology
`HFD-420; W0: 22 Mailstop 4447
`Center for Drug Evaluation and Research
`
`LABEL AND LABELING REVIEW
`
`DATE OF REVIEW:
`
`May 25, 2006
`
`NDA#:
`NAME OF DRUG:
`
`22-030 (IND#: 51,232)
`Fesoterodine Fumarate Extended-release Tablets
`4 mg and 8 mg
`
`_ NDA HOLDER:
`
`Schwarz Pharma
`
`I.
`
`INTRODUCTION:
`
`This consult was written in response to a request from the Division of Reproductive and Urologic
`Products (HFD-580) for a review of the proposed container labels, carton and insert labeling of
`Fesoteridine Fumarate Extended-release Tablets. DMETS reviewed the previously proposed proprietary
`name,—"—-——~—- , for IND# 51,232 in ODS Consult 05—0071 which was found acceptable by DMETS on
`November 18,2005. Additionally, the sponsor submitted an alternate name, A for evaluation.
`The Division of Drug Marketing, Advertising and Communications (DDMAC) did not recommend the
`
`use of the proprietary name, ( M ,from a promotional perspective because'
`.
`N The Division concurred with DDMAC. Thus, DMETS did
`not proceed with the safety review of the name / At this time, the sponsor has not submitted a
`proprietary name for this product. They have not decided if they want to proceed with ‘ /’ or choose
`a different name.
`
`. hi4§
`
`PRODUCT INFORMATION '
`
`Fesoterodine FumarateIS a competitive muscarinic receptor antagonist andis indicated1n the treatment
`V of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. The
`recommended starting dose1S 4 mg once daily and based on individual patient response, the dose may
`be increased to 8 mg once daily. It should be taken once daily with liquid and swallowed whole with or
`without food and should not be chewed, divided, or crushed. It will be supplied1n 4 mg and 8 mg
`tablets and packagedin bottles of 30 and 90 tablets.
`
`

`

`II.
`
`LABELING, PACKAGING, AND SAFETY RELATED ISSUES
`
`In the review of the container labels, carton and insert labeling of Fesoteridine Fumarate Extended-
`release Tablets, DMETS has attempted to focus on safety issues relating to possible medication errors.
`DMETS has identified the following areas of possible improvement, which might minimize potential
`user error.
`
`A.
`
`GENERAL COMMENTS
`
`1.
`
`2.
`
`3.
`
`./’/’.A
`
`2"]:
`
`h
`
`' ’ T
`
`4'
`
`will
`
`B.
`
`CONTAINER LABEL (30 count and 90 count)
`
`1.
`
`2.
`
`See GENERAL COMMENTS.
`
`Ensure that the 30-count and 90-count unit-of—use container has a child resistant closure
`to be in accordance with the Poison Prevention Act. We refer you to
`16 CFR 1700.15 and 1700.15 for guidance.
`
`C.
`
`CONTAINER LABEL (Professional Sample Blister, 7-count)
`
`1.
`
`'
`
`See GENERAL COMMENT A2.
`
`2.
`
`/‘\.
`
`/
`
`Q
`
`. 33(4)
`
`33(4) ..
`
`hi4?
`
`

`

`Figure 1.
`
`4.
`
`
`Figure 2.
`
`M4}
`
`
`
`DMETS considers a configuration similar to that in Figure 1 acceptable.
`However, DMETS considers a configuration similar to that in Figure 2 above
`
`
`
`CARTON LABELING (Professional Sample, One blister card)
`
`1.
`
`2.
`
`See GENERAL COMMENTS.
`
`Include a usual dose statement. See 21 CFR 201.55.
`
`CARTON LABELING (Professional Sample Display, 7 x 7)
`
`1.
`
`See GENERAL COMMENTS.
`
`3.
`
`-
`
`Include a usual dose statement. See 21 CFR 201.55
`
`INSERT LABELING
`
`Repeat Precautions Information for Patients at the end of the package insert labeling.
`
`M4)
`
`

`

`This is a representation of an electronic record that was signed electronically and
`tMSmmebflmnmmmflmhndflmehdecflwmmm.
`
`Linda Wisniewski
`7/18/2006 03:55:05 PM
`DRUG SAFETY OFFICE REVIEWER
`
`Alina Mahmud
`7/18/2006 03:56:30 PM
`DRUG SAFETY OFFICE REVIEWER
`
`Carol Holquist
`7/18/2006 04:42:43 PM
`DRUG SAFETY OFFICE REVIEWER
`
`