CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`209089Orig1s000
` 209090Orig1s000
`
`
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`

`

`1.3.3 Debannent Certification
`
`
`
`levocetirizine dihydrochloride tablet - NDA 209089
`
`
`
`
`
`
`DEBARMENT CERTIFICATION
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi-aventis US. LLC, A SANOFI COMPANY, as the authorized US Agent for UCB, hereby
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`certifies that it did not and will not use in any capacity the services of any person debarred under
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`section 306 of the Federal Food, Drug and Cosmetic Act in connection with this application.
`
`
`
`
`
`
`
`
`
`
`
`UCB also provided debarment certification in NDA 22—064 in Module 1.3.1.3.
`
`
`
`Paw
`
`
`Cynthi
`Director
`
`
`
`
`
`Taylor Psaras, P
`
`
`
`Global Regulatory Affairs
`
`
`
`
`Sanofi US Services Inc.
`
`
`
`
`
`on behalf of sanofi-aventis US. LLC,
`A SANOFI COMPANY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Property of the Sanofi group - strictly confidential
`
`
`
`
`Page 1
`
`
`
`Reference ID: 4059451
`Reference ID: 4059451
`
`

`

`1.3.3 Debarment Certification
`
`
`
`levocettrizine dihydrochloride oral solution - NDA 209090
`
`
`
`
`
`
`
`DEBARMENT CERTIFICATION
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi-aventis US. LLC, A SANOFI COMPANY, as the authorized US Agent for UCB, hereby
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`certifies that it did not and will not use in any capacity the services of any person debarred under
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`section 306 of the Federal Food, Drug and Cosmetic Act in connection with this application.
`
`
`
`
`
`
`
`
`
`
`
`
`UCB also provided debarment certification in NDA 22—157 in Module 1.3.1.3.
`
`
`
`Director
`
`,
`
`Global Regulatory Affairs
`Sanofi US Services Inc.
`
`on behalf of sanofi-aventis US. LLC,
`A SANOFI COMPANY
`
`
`
`
`
`
`Property of the Sanofi group - strictly confidential
`
`
`
`Page 1
`
`
`
`
`

`

`ACTION PACKAGE CHECKLIST
`
`APPLICATION INFORMATION1
`NDA Supplement #
`If NDA, Efficacy Supplement Type:
`NDA # 209089
`(an action package is not required for SE8 or SE9 supplements)
`BLA Supplement #
`BLA #
`Proprietary Name: Xyzal 24 HR
`Established/Proper Name: levocetirizine dihydrochloride
`Dosage Form: tablet
`RPM: Sherry Stewart
`
`Applicant: UCB, Inc.
`Agent for Applicant (if applicable): Sanofi-aventis U.S., LLC
`
`NDA Application Type:
`Efficacy Supplement:
`
` 505(b)(1)
` 505(b)(1)
`
` 505(b)(2)
` 505(b)(2)
`
`BLA Application Type:
`Efficacy Supplement:
`
` 351(k)
` 351(k)
`
` 351(a)
` 351(a)
`
`Division: Division of Nonprescription Drug Products (DNDP)
`For ALL 505(b)(2) applications, two months prior to EVERY action:
`
`• Review the information in the 505(b)(2) Assessment and submit
`the draft2 to CDER OND IO for clearance.
`• Check Orange Book for newly listed patents and/or
`exclusivity (including pediatric exclusivity)
`
` No changes
` New patent/exclusivity (notify CDER OND IO)
`Date of check:
`
`Note: If pediatric exclusivity has been granted or the pediatric
`information in the labeling of the listed drug changed, determine whether
`pediatric information needs to be added to or deleted from the labeling of
`this drug.
`
`(cid:2) Actions
`Proposed action
`•
`• User Fee Goal Date is January 31, 2017
`Previous actions (specify type and date for each action taken)
`•
`(cid:2) If accelerated approval or approval based on efficacy studies in animals, were promotional
`materials received?
`Note: Promotional materials to be used within 120 days after approval must have been
`submitted (for exceptions, see
`http://www fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
`nces/ucm069965.pdf). If not submitted, explain
`(cid:2) Application Characteristics 3
`
` AP
`
` TA CR
`
` None
`
` Received
`
`1 The Application Information Section is (only) a checklist. The Contents of Action Package Section (beginning on page 2) lists
`the documents to be included in the Action Package.
`2 For resubmissions, 505(b)(2) applications must be cleared before the action, but it is not necessary to resubmit the draft 505(b)(2)
`Assessment to CDER OND IO unless the Assessment has been substantively revised (e.g., new listed drug, patent certification
`revised).
`3 Answer all questions in all sections in relation to the pending application, i.e., if the pending application is an NDA or BLA
`supplement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA.
`
`Version: 01/04/17
`
`Reference ID: 4052420
`
`

`

`NDA/BLA #
`Page 2
`
`Review priority:
` Priority
` Standard
`Chemical classification (new NDAs only): oral antihistamine Hz receptor antaganist
`(confirm chemical classification at time of approval)
`
` Fast Track
` Rolling Review
` Orphan drug designation
` Breakthrough Therapy designation
`(NOTE: Set the submission property in DARRTS and notify the CDER Breakthrough Therapy Program Manager;
`Refer to the “RPM BT Checklist for Considerations after Designation Granted” for other required actions: CST SharePoint)
`
` Rx-to-OTC full switch
` Rx-to-OTC partial switch
` Direct-to-OTC
`
`NDAs: Subpart H BLAs: Subpart E
`
` Accelerated approval (21 CFR 314.510)
` Accelerated approval (21 CFR 601.41)
`
` Restricted distribution (21 CFR 314.520)
` Restricted distribution (21 CFR 601.42)
` Subpart I Subpart H
`
` Approval based on animal studies
` Approval based on animal studies
`
` Submitted in response to a PMR REMS:
` Submitted in response to a PMC
` Submitted in response to a Pediatric Written Request
`
`Comments:
`
` MedGuide
` Communication Plan
` ETASU
` MedGuide w/o REMS
` REMS not required
`
`(cid:2) BLAs only: Is the product subject to official FDA lot release per 21 CFR 610.2
`(approvals only)
`(cid:2) Public communications (approvals only)
`• Office of Executive Programs (OEP) liaison has been notified of action
`
`•
`
`Indicate what types (if any) of information were issued
`
`(cid:2) Exclusivity
`Is approval of this application blocked by any type of exclusivity (orphan, 5-year
`•
`NCE, 3-year, pediatric exclusivity)?
`If so, specify the type
`•
`(cid:2) Patent Information (NDAs only)
`
` Yes
`
` No
`
` No
`
` Yes
` None
` FDA Press Release
` FDA Talk Paper
` CDER Q&As
` Other
`
` No
`
`
` Yes
`
`•
`
`Patent Information:
`Verify that form FDA-3542a was submitted for patents that claim the drug for
`which approval is sought.
`
` Verified
` Not applicable because drug is
`an old antibiotic.
`
`CONTENTS OF ACTION PACKAGE
`Officer/Employee List
`(cid:2) List of officers/employees who participated in the decision to approve this application and
`consented to be identified on this list (approvals only)
`Documentation of consent/non-consent by officers/employees
`
` Included
`
` Included
`
`Reference ID: 4052420
`
`

`

`NDA/BLA #
`Page 3
`
`(cid:2) Copies of all action letters (including approval letter with final labeling)
`
`AP 1/31/17
`
`Action Letters
`
`Labeling
`
`(cid:2) Package Insert (write submission/communication date at upper right of first page of PI)
`• Most recent draft labeling (if it is division-proposed labeling, it should be in
`track-changes format)
`• Original applicant-proposed labeling
`
`(cid:2) Medication Guide/Patient Package Insert/Instructions for Use/Device Labeling (write
`submission/communication date at upper right of first page of each piece)
`
`• Most-recent draft labeling (if it is division-proposed labeling, it should be in
`track-changes format)
`
`• Original applicant-proposed labeling
`
`(cid:2) Labels (full color carton and immediate-container labels) (write
`submission/communication date on upper right of first page of each submission)
`
`• Most-recent draft labeling
`
` Included
`
` Included
`
` Medication Guide
` Patient Package Insert
` Instructions for Use
` Device Labeling
` None
` Included
`
` Included
`
` Included
`
`(cid:2) Proprietary Name
`• Acceptability/non-acceptability letter(s) (indicate date(s)) June 8, 2016
`Review(s) (indicate date(s) May 26, 2016
`•
`
`
`
`
`(cid:2) Labeling reviews (indicate dates of reviews)
`
`Administrative / Regulatory Documents
`
`(cid:2) RPM Filing Review4/Memo of Filing Meeting (indicate date of each review)
`(cid:2) All NDA 505(b)(2) Actions: Date each action cleared by 505(b)(2) Clearance Committee
`
`(cid:2) NDAs/NDA supplements only: Exclusivity Summary (signed by Division Director)
`(cid:2) Application Integrity Policy (AIP) Status and Related Documents
`http://www fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/default.htm
`
` None
`RPM:
`DMEPA:
` None 12/16/16
`DMPP/PLT (DRISK):
` None
` None
`OPDP:
` None
`SEALD:
`CSS:
` None
`Product Quality
` None
`Other:
` None
`
`5/16/16
`
` Not a (b)(2) 1/24/17
`
` Completed (Do not include)
`
`• Applicant is on the AIP
`
` Yes
`
` No
`
`4 Filing reviews for scientific disciplines are NOT required to be included in the action package.
`
`Reference ID: 4052420
`
`

`

`NDA/BLA #
`Page 4
`
`•
`
`This application is on the AIP
`o If yes, Center Director’s Exception for Review memo (indicate date)
`o If yes, OC clearance for approval (indicate date of clearance
`communication)
`(cid:2) Pediatrics (approvals only)
`• Date reviewed by PeRC
`If PeRC review not necessary, explain:
`
` Yes
`
`
`
` No
`
` Not an AP action
`
`Not applicable
`
`(cid:2) Breakthrough Therapy Designation
`
`•
`•
`
`•
`
`Breakthrough Therapy Designation Letter(s) (granted, denied, an/or rescinded)
`CDER Medical Policy Council Breakthrough Therapy Designation
`Determination Review Template(s) (include only the completed template(s) and
`not the meeting minutes)
`CDER Medical Policy Council Brief – Evaluating a Breakthrough Therapy
`Designation for Rescission Template(s) (include only the completed template(s)
`and not the meeting minutes)
`
`(completed CDER MPC templates can be found in DARRTS as clinical reviews or on
`the MPC SharePoint Site)
`(cid:2) Outgoing communications: letters, emails, and faxes considered important to include in
`the action package by the reviewing office/division (e.g., clinical SPA letters, RTF letter,
`Formal Dispute Resolution Request decisional letters, etc.) (do not include OPDP letters
`regarding pre-launch promotional materials as these are non-disclosable; do not include
`Master File letters; do not include previous action letters, as these are located elsewhere
`in package)
`(cid:2) Internal documents: memoranda, telecons, emails, and other documents considered
`important to include in the action package by the reviewing office/division (e.g.,
`Regulatory Briefing minutes, Medical Policy Council meeting minutes)
`(cid:2) Minutes of Meetings
`If not the first review cycle, any end-of-review meeting (indicate date of mtg)
`•
`
`•
`
`Pre-NDA/BLA meeting (indicate date of mtg)
`
`EOP2 meeting (indicate date of mtg)
`•
`• Mid-cycle Communication (indicate date of mtg)
`Late-cycle Meeting (indicate date of mtg)
`•
`• Other milestone meetings (e.g., EOP2a, CMC focused milestone meetings)
`(indicate dates of mtgs)
`(cid:2) Advisory Committee Meeting(s)
`• Date(s) of Meeting(s)
`
`Decisional and Summary Memos
`(cid:2) Office Director Decisional Memo (indicate date for each review)
`
`Division Director Summary Review (indicate date for each review)
`
`Cross-Discipline Team Leader Review (indicate date for each review)
`
`PMR/PMC Development Templates (indicate total number)
`Clinical
`
` N/A
`
`
`
`
`
`
`
`Acknowledgement Letter: 4/14/16
`74 day Letter: 6/13/16
`Information Requests; 5/31/16;
`9/1/16; 9/21/16; 12/21/16;
`Labeling PMR/PMC Discussion
`Comments: 12/28/16
`Memorandum of Informal
`Teleconference 1/13/16
`
` N/A or no mtg
` No mtg Pre-IND meeting
`10/1/15
` No mtg
` N/A
` N/A
`
`
`
` No AC meeting
`
`
` None
`
` None 1/30/17
`
` None 1/10/17
`
` None
`
`Reference ID: 4052420
`
`

`

`NDA/BLA #
`Page 5
`
`(cid:2) Clinical Reviews
`Clinical Team Leader Review(s) (indicate date for each review)
`•
`
`•
`
`•
`
`Clinical review(s) (indicate date for each review)
`
`Social scientist review(s) (if OTC drug) (indicate date for each review)
`
`(cid:2) Financial Disclosure reviews(s) or location/date if addressed in another review
` OR
` If no financial disclosure information was required, check here
` review/memo explaining why not (indicate date of review/memo)
`
` and include a
`
`(cid:2) Clinical reviews from immunology and other clinical areas/divisions/Centers (indicate
`date of each review)5
`(cid:2) Controlled Substance Staff review(s) and Scheduling Recommendation (indicate date of
`each review)
`(cid:2) Risk Management
`REMS Documents and REMS Supporting Document (indicate date(s) of
`•
`submission(s))
`REMS Memo(s) and letter(s) (indicate date(s))
`Risk management review(s) and recommendations (including those by OSE and
`CSS) (indicate date of each review and indicate location/date if incorporated
`into another review)
`(cid:2) OSI Clinical Inspection Review Summary(ies) (include copies of OSI letters to
`investigators)
`
`•
`•
`
` None
`
`Clinical Microbiology
`(cid:2) Clinical Microbiology Team Leader Review(s) (indicate date for each review)
`Clinical Microbiology Review(s) (indicate date for each review)
`Biostatistics
`(cid:2) Statistical Division Director Review(s) (indicate date for each review)
`Statistical Team Leader Review(s) (indicate date for each review)
`Statistical Review(s) (indicate date for each review)
`Clinical Pharmacology
` None
`(cid:2) Clinical Pharmacology Division Director Review(s) (indicate date for each review)
`Clinical Pharmacology Team Leader Review(s) (indicate date for each review)
`Clinical Pharmacology review(s) (indicate date for each review)
`(cid:2) OSI Clinical Pharmacology Inspection Review Summary (include copies of OSI letters)
`
` None
`
` No separate review
`Wang: 12/12/16
`Gierhart: 11/15/16
` None Pike-McCrudden
`12/22/16
`Clinical Review (Gierhart) p, 33
`No new studies performed,
`therefore no new financial
`disclosure forms.
`
` None
`
` N/A
`
`
`
`
`
` None
`
` None requested
`
` No separate review
` None       
`
` No separate review
` No separate review
` None 12/21/16
`
` No separate review
` No separate review
` None 12/22/16
` None requested
`
`5 For Part 3 combination products, all reviews from the reviewing Center(s) should be entered into the official archive (for further
`instructions, see “Section 508 Compliant Documents: Process for Regulatory Project Managers” located in the CST electronic
`repository).
`
`Reference ID: 4052420
`
`

`

`NDA/BLA #
`Page 6
`
`Nonclinical
`(cid:2) Pharmacology/Toxicology Discipline Reviews
`• ADP/T Review(s) (indicate date for each review)
`Supervisory Review(s) (indicate date for each review)
`•
`Pharm/tox review(s), including referenced IND reviews (indicate date for each
`•
`review)
`(cid:2) Review(s) by other disciplines/divisions/Centers requested by P/T reviewer (indicate date
`for each review)
`
` None
`
` No separate review
` No separate review
`
` None 12/2/16
`
` None
`
`(cid:2) Statistical review(s) of carcinogenicity studies (indicate date for each review)
`
` No carc
`
`(cid:2) ECAC/CAC report/memo of meeting
`
`(cid:2) OSI Nonclinical Inspection Review Summary (include copies of OSI letters)
`Product Quality
`(cid:2) Product Quality Discipline Reviews6
`
` None
`
`•
`
`Tertiary review (indicate date for each review)
`
`•
`•
`
`Secondary review (e.g., Branch Chief) (indicate date for each review)
`Integrated Quality Assessment (contains the Executive Summary and the primary
`reviews from each product quality review discipline) (indicate date for each
`review)
`(cid:2) Reviews by other disciplines/divisions/Centers requested by product quality review team
`(indicate date of each review)
`(cid:2) Environmental Assessment (check one) (original and supplemental applications)
` Categorical Exclusion (indicate review date)(all original applications and
` all efficacy supplements that could increase the patient population)
` Review & FONSI (indicate date of review)
`
` Review & Environmental Impact Statement (indicate date of each review)
`
`(cid:2) Facilities Review/Inspection
` Facilities inspections (indicate date of recommendation; within one week of
`taking an approval action, confirm that there is an acceptable recommendation
`before issuing approval letter) (only original applications and efficacy
`supplements that require a manufacturing facility inspection(e.g., new strength,
`manufacturing process, or manufacturing site change)
`
` None
`Included in P/T review, page
` None requested
`
` None 12/16/16
`
` None 12/16/16
`
` None
`
` None
`
`P. 33 CMC Review
`
`
`
`
`
` Acceptable
`Re-evaluation date:
` Withhold recommendation
` Not applicable
`
`6 Do not include Master File (MF) reviews or communications to MF holders. However, these documents should be made available
`upon signatory request.
`
`Reference ID: 4052420
`
`

`

`NDA/BLA #
`Page 7
`
`Day of Approval Activities
`
`(cid:2) For all 505(b)(2) applications:
`• Check Orange Book for newly listed patents and/or exclusivity (including
`pediatric exclusivity)
`
`Finalize 505(b)(2) assessment
`•
`(cid:2) For Breakthrough Therapy (BT) Designated drugs:
`• Notify the CDER BT Program Manager
`(cid:2) For products that need to be added to the flush list (generally opioids): Flush List
`• Notify the Division of Online Communications, Office of Communications
`(cid:2) Send a courtesy copy of approval letter and all attachments to applicant by fax or secure
`email
`(cid:2) If an FDA communication will issue, notify Press Office of approval action after
`confirming that applicant received courtesy copy of approval letter
`(cid:2) Ensure that proprietary name, if any, and established name are listed in the
`Application Product Names section of DARRTS, and that the proprietary name is
`identified as the “preferred” name
`(cid:2) Ensure Pediatric Record is accurate
`
`(cid:2) Send approval email within one business day to CDER-APPROVALS
`
` No changes
` New patent/exclusivity (Notify
`CDER OND IO)
`
` Done
`
` Done
`(Send email to CDER OND IO)
` Done
`
` Done
`
` Done
`
` Done
`
` Done
`
` Done
`
`Reference ID: 4052420
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`SHERRY A STEWART
`02/07/2017
`
`Reference ID: 4052420
`
`

`

`Stewart, Sheri-z
`
`From:
`Sent:
`
`To:
`
`Subject:
`
`Hi Cynthia,
`
`Stewart, Sherry
`Wednesday, December 21, 2016 4:05 PM
`
`cynthia.psaras@sanofi.com
`
`NDA 209089, Xyzal 24 HR (levocetirizine) Request for Information—Response Required
`
`Please reply to this email to confirm receipt.
`
`Please refer to original new drug application (N DA) 209089, Xyzal°24HR for the labeling information request below:
`
`Outside Drug Facts label (DFL)
`
`1. Remove "Original Prescription Strength" from PDP on all labels. Per policy, only full switches may use this language.
`
`NDA 209089 is a partial-OTC switch and does not qualify for this language.
`
`2. Per §201.61 (c), the statement of identity (SOI) shall be presented in bold face type on principal display panel (PDP).
`
`Update SOI to comply with §201.61 (c).
`3. Replace all placeholder "Xs" with actual NDC number on cartons and immediate containers to comply with §207.35
`
`(MB)-
`
`4. Update country of origin to "Switzerland
`
`ma)" as these countries are the manufacturers of API.
`
`5. Revise statement,
`
`02)“) to "Clinically proven 24 hour relief'I on 10-count carton to
`
`comply with drug class labeling for antihistamines.
`
`6. Refer to 45-count Bonus carton. Per non-prescription drug labeling policy, the net quantity statement can reflect the
`
`"free" amount by placing a l'\" or "X" over the original package size quantity and placing the new quantity on the PDP.
`Update the 45-count Bonus carton to reflect this policy.
`7. Refer to 35-,45-,55-and 80-count carton statement,
`
`M“)
`0)“)
`
`«mm-- The agency's Division of Pulmonary, Allery, and Rheumatology cites only three
`triggers studied. Change listed triggers to "indoor and outdoor allergens" to comply with class labeling for
`antihistamines.
`
`8. There are ten "X" placeholders on cartons and immediate containers that do not appear to be labeling. Provide
`explanation for these placeholders.
`
`9. Place statement, "Read directions and warnings before use. Keep this carton. It has important information" on carton
`
`as this NDA is not marketed with a consumer information leaflet (CIL).
`
`Drug Facts Label (DFL)
`
`1. In Directions, change
`
`(5)“) to II
`
`once daily in the evening" to be consistent with prescription labeling.
`
`2. In Inactive ingredients, change "polyethylene glycol'I to "polyethylene glycol 400" which states the correct excipient
`used.
`
`3. In Questions or Comments?, Replace the placeholder Xs with actual telephone number on cartons and immediate
`
`container bottles. §201.66 (c)(9) recommends that the label include the days of the week and times that the toll-free
`
`number is in operation.
`
`Please make the above revisions to draft labeling and submit revised labeling as an amendment to the application by
`
`COB Monday January 6, 2017.
`
`If you have any questions, please let me know.
`
`Thank you and best regards,
`
`Reference ID: 4032102
`
`

`

`Sherry Stewart, PharmD
`(cid:53)(cid:72)(cid:74)(cid:88)(cid:79)(cid:68)(cid:87)(cid:82)(cid:85)(cid:92)(cid:51)(cid:85)(cid:82)(cid:77)(cid:72)(cid:70)(cid:87)(cid:48)(cid:68)(cid:81)(cid:68)(cid:74)(cid:72)(cid:85)
`
`(cid:39)(cid:76)(cid:89)(cid:76)(cid:86)(cid:76)(cid:82)(cid:81)(cid:82)(cid:73)(cid:49)(cid:82)(cid:81)(cid:83)(cid:85)(cid:72)(cid:86)(cid:70)(cid:85)(cid:76)(cid:83)(cid:87)(cid:76)(cid:82)(cid:81)(cid:39)(cid:85)(cid:88)(cid:74)(cid:51)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:86)
`
`(cid:50)(cid:73)(cid:73)(cid:76)(cid:70)(cid:72)(cid:82)(cid:73)(cid:39)(cid:85)(cid:88)(cid:74)(cid:40)(cid:89)(cid:68)(cid:79)(cid:88)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:44)(cid:57)
`
`(cid:38)(cid:72)(cid:81)(cid:87)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:39)(cid:85)(cid:88)(cid:74)(cid:40)(cid:89)(cid:68)(cid:79)(cid:88)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:81)(cid:71)(cid:53)(cid:72)(cid:86)(cid:72)(cid:68)(cid:85)(cid:70)(cid:75)
`
`(cid:22)(cid:19)(cid:20)(cid:16)(cid:26)(cid:28)(cid:25)(cid:16)(cid:28)(cid:25)(cid:20)(cid:27)
`
`(cid:54)(cid:75)(cid:72)(cid:85)(cid:85)(cid:92)(cid:17)(cid:54)(cid:87)(cid:72)(cid:90)(cid:68)(cid:85)(cid:87)(cid:35)(cid:73)(cid:71)(cid:68)(cid:17)(cid:75)(cid:75)(cid:86)(cid:17)(cid:74)(cid:82)(cid:89)
`
`The information transmitted in this electronic communication is intended only for the person or entity to whom it is addressed and may contain confidential and/or
`privileged material. Any review, retransmission, dissemination or other use of or taking of any action in reliance upon this information by persons or entitles other
`than the intended recipient is prohibited.
`
`Reference ID: 4032102
`
`2
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`SHERRY A STEWART
`12/28/2016
`
`Reference ID: 4032102
`
`

`

`Stewart, Sher
`
`From:
`Sent:
`
`To:
`
`Subject:
`
`Hi Cynthia,
`
`Stewart, Sherry
`Wednesday, December 28, 2016 8:46 AM
`
`cynthia.psaras@sanofi.com
`
`NDA 209090 Children's Xyzal 24 HR (levocetirizine) Request for Information—Response
`Required
`
`Please reply to this email to confirm receipt.
`
`Please refer to original new drug application (N DA) 209090, Children's Xyzal°24HR for the labeling information request
`below:
`
`Outside Drug Facts label [DFLI
`1. Per §201.61 (c), the statement of identity (SOI) shall be presented in bold face type on principal display panel (PDP).
`
`Update SOI to comply with §201.61 (c).
`
`2. Replace the placeholder "Xs" with actual NDC number to comply with §207.35 (b)(3).
`
`3. Change "ml" to "mL" in statement of identity AND net quantity on carton and immediate container.
`
`4. Change declaration of net quantity to boldface font to comply with §201.62 (g).
`
`5. Update country of origin to "Switzerland and Belgium as these countries are the manufacturers of API."
`6. Revise statement,
`M“) to "Clinically proven 24 hour relief" on 10-count carton to
`comply with drug class labeling.
`7. Recommend placing statement, "Read directions and warnings before use. Keep this carton. It has important
`
`information" on carton as this NDA is n_ot marketed with a consumer information leaflet (CIL).
`
`8. Include an image of the dosing cup on the principal display panel of carton labeling. In addition, include an image of
`
`APPEARS THIS WAY ON ORIGINAL
`the dosing cup on the side panel above the
`phrase ”Use Only With Enclosed Dosing Cup”. The image of cup should appear empty with measurement lines visible.
`
`Drug Facts Label {DFLI
`1. . In Directions, change
`
`(5) (4) to II
`
`once daily in the evening" to be consistent with prescription labeling.
`
`2. In Questions or Comments?, Replace the placeholder Xs with actual telephone number on cartons and immediate
`
`container bottles. We also recommend that the label include the days of the week and times that the toll-free number is
`in operation.
`
`Please make the above revisions to draft labeling and submit revised labeling as an amendment to the application by
`
`COB Friday January 6, 2017.
`
`Thank you and best regards,
`
`Slierry Stewart, Tfiarml)
`Regulatory Project Manager
`
`Division of Nonprescription Drug Products
`
`Office of Drug Evaluation IV
`
`Center for Drug Evaluation and Research
`301 -796—961 8
`
`Sherry.Stewart@fda.hhs.gov
`
`Reference ID: 4034278
`
`

`

`The information transmitted in this electronic communication is intended only for the person or entity to whom it is addressed and may contain confidential and/or
`privileged material. Any review, retransmission, dissemination or other use of or taking of any action in reliance upon this information by persons or entitles other
`than the intended recipient is prohibited.
`
`Reference ID: 4034278
`
`2
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`SHERRY A STEWART
`12/28/2016
`
`Reference ID: 4034278
`
`

`

`Stewart, Sher
`
`From:
`Sent:
`
`To:
`
`Cc:
`
`Subject:
`
`Hi Swapan,
`
`Stewart, Sherry
`Thursday, November 17, 2016 11:15 AM
`
`De, Swapan K
`
`Scroggs, Betsy (Ruth.Scroggs@fda.hhs.gov); Livornese, Karen; Adah, Steven; Lorick,
`Kevin
`
`NDA 209089 and 209090 Xyzal, Internal Request for Information — Respond by
`11/23/16
`
`Karen Livornese, our labeling reviewer has the follow request for information regarding the above mentioned NDAs:
`
`1. The Distributor label states:
`
`The trade dress of this Xyzal" package
`
`is subject to trademark protection.
`
`Dist. By: Chattem, Inc., a Sanoli Company,
`
`Chattanooga, TN 37409-0219
`
`@2017 Origin: Switzerland
`
`Please confirm origin of foreign country is acceptable.
`
`Please respond via reply all email by 11/23/16.
`
`Let me know if you have any questions,
`
`Thanks,
`
`Sherry Stewart, Tharml)
`Regulatory Project Manager
`
`Division of Nonprescription Drug Products
`
`Office of Drug Evaluation IV
`
`Center for Drug Evaluation and Research
`
`301 -796-961 8
`
`Sher
`
`.Stewart
`
`fda.hhs. ov
`
`The information transmitted in this electronic communication is intended onlyfor the person or entity to whom it is addressed and may contain confidential and/or
`privileged material. Any review, retransmission, dissemination or other use of or taking of any action in reliance upon this information by persons or entitles other
`than the intended recipient is prohibited.
`
`Reference ID: 401 5333
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`SHERRY A STEWART
`11/17/2016
`
`Reference ID: 4015333
`
`

`

`Stewart, Sher
`
`From:
`Sent:
`
`To:
`Cc:
`
`Subject:
`
`Hi Betsy and Swapan:
`
`Stewart, Sherry
`Thursday, November 17, 2016 11:11 AM
`
`Scroggs, Betsy (Ruth.Scroggs@fda.hhs.gov)
`Livornese, Karen; Lorick, Kevin; Adah, Steven; Brum, Dan (Dan.Brum@fda.hhs.qov)
`
`NDA 209089 and 209090 Xyzal, Internal Request for Information, Respond by 11/23/16
`
`The IDS/Labeling Reviewer Karen Livornese has the following request for information with regard to the above
`
`mentioned pending NDAs.
`
`0N4)». According to the SOP:
`1. The PDP displays "
`”We only allow this statement as a flag on the PDP for complete switches (i.e., the prescription product no longer exists
`because all indications are switched).
`
`Exemptions from this policy will be made on a case-by-case basis, and such exemptions will be cleared by ODE IV (e.g.,
`D)«)).II
`
`Since this is a partial switch, is this acceptable for these two NDAs?
`
`Please provide your response via reply all email by 11/23/16.
`
`Let me know if you have any questions,
`
`Thanks,
`
`Sherry Stewart, Tfiarml)
`Regulatory Project Manager
`
`Division of Nonprescription Drug Products
`
`Office of Drug Evaluation IV
`
`Center for Drug Evaluation and Research
`
`301 -796—961 8
`
`Sherry.Stewart@fda.hhs.gov
`
`The information transmitted in this electronic communication is intended onlyfor the person or entity to whom it is addressed and may contain confidential and/or
`privileged material. Any review, retransmission, dissemination or other use of or taking ofany action in reliance upon this information by persons or entities other
`than the intended recipient is pmhibited.
`
`Reference ID: 401 5331
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`SHERRY A STEWART
`11/17/2016
`
`Reference ID: 4015331
`
`

`

`Stewart, Sher
`
`From:
`Sent:
`
`To:
`
`Subject:
`
`Hi Cynthia,
`
`Stewart, Sherry
`Wednesday, September 21, 2016 4:44 PM
`
`cynthia.psaras@sanofi.com
`
`NDA 209089—Xyzal—Request for Information—Response Required
`
`Please reply to this email to acknowledge receipt.
`
`Regarding the above referenced NDA, we have the following request for information.
`
`1.
`
`In NDA 209089 SDN2 dated 3/31/16, the "Tabular listing of clinical studies (allergic rhinitis)" (located in Module
`
`5.2 in the NDA 209089 3/31/16 submission) on pg. 29 states that Sanofi was planning on submitting two full
`
`complete study reports for A00430 and A00431 in Module 5.3.5.1; however, no such study reports exist in that
`
`module. Submit these two study reports in Module 5.3.51 for Original NDA 209089.
`
`Submit the requested information to me via email by close of business 9/30/16 and follow up with a formal submission
`to the NDA.
`
`If you have any questions, please let me