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Application Number: Nda 21-330/S-21

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Application Number: Nda 21-330/S-21 CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: NDA 21-330/S-21 Trade Name: Nicorette Generic or Proper nicotine polacrilex Name: Sponsor: GlaxoSmithKline Consumer Healthcare Approval Date: August 10, 2018 Indication: provides for a new mint flavor coated lozenge CENTER FOR DRUG EVALUATION AND RESEARCH NDA 21-330/S-21 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter X Other Action Letters Labeling X REMS Summary Review Officer/Employee List Office Director Memo Cross Discipline Team Leader Review Clinical Review X Chemistry Review Environmental Assessment Pharmacology/Toxicology X Statistical Review Clinical Microbiology Clinical Pharmacology X Other Reviews X Risk Assessment and Risk Mitigation Review(s) Proprietary Name Review Administrative/Correspondence Document(s) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: NDA 21-330/S-21 APPROVAL LETTER DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 021330/S-021 SUPPLEMENT APPROVAL GlaxoSmithKline Consumer Healthcare Attention: Julia Kim Senior Director, US Regulatory Affairs 184 Liberty Corner Road, Suite 200 Warren, NJ 07059 Dear Ms. Kim: Please refer to your Supplemental New Drug Application (sNDA) dated and received February 22, 2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Nicorette (nicotine polacrilex) lozenges, 2 mg and 4 mg. We acknowledge receipt of your major amendment dated June 5, 2018, which extended the goal date by two months. This “Prior Approval” sNDA provides for a new mint flavor coated lozenge which will be referred to as “Coated Ice Mint”. 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 agreed-upon labeling text. LABELING Submit final printed labeling (FPL), as soon as they are available, but no more than 30 days after they are printed. The FPL must be identical to the labels and labeling listed in the table below, and must be in the “Drug Facts” format (21 CFR 201.66), where applicable. Submitted Labeling Date(s) Submitted 20-ct, 2 mg Immediate container “Flip- February 22, 2018 Pack” (front) 20-ct, 4 mg Immediate container “Flip February 22, 2018 Pack” (front) 20-ct, 2 mg and 4 mg Immediate February 22, 2018 container “Flip-Pack” (back) 20-ct, 2 mg outer carton container backer February 22, 2018 card (back) Reference ID: 4305123 NDA 21330/S021 Page 2 20-ct, 2 mg outer carton container backer June 25, 2018 card (front) 20-ct, 4 mg outer carton container backer February 22, 2018 card (back) 20-ct, 4 mg outer carton container backer card (front) June 25, 2018 80-ct (4x20 pack), 2 mg outer carton February 22, 2018 container backer card (back) 80-ct (4x20 pack), 2 mg outer carton June 25, 2018 container backer card (front) 80-ct (4x20 pack), 4 mg outer carton February 22, 2018 container backer card (back) 80-ct (4x20 pack), 4 mg outer carton June 25, 2018 container backer card (front) 120-ct (6x20 pack), 2 mg Club pack outer carton container backer card (front June 25, 2018 and back) 120-ct (6x20 pack), 4 mg Club pack June 25, 2018 outer carton container backer card (front and back) Consumer Information leaflet (User’s February 22, 2018 Guide leaflet) The FPL should be submitted electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (May 2015, Revision 3). For administrative purposes, designate this submission “Final Printed Labeling for approved NDA 21330/S-021.” Approval of this submission by FDA is not required before the labeling is used. DRUG REGISTRATION AND LISTING All drug establishment registration and drug listing information is to be submitted to FDA electronically, via the FDA automated system for processing structured product labeling (SPL) files (eLIST). At the time that you submit your final printed labeling (FPL), the content of labeling (Drug Facts) should be submitted in SPL format as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Information on submitting SPL files using eLIST may be found in the guidance for industry titled “SPL Standard for Content of Labeling Technical Qs and As” at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. In addition, representative container or carton labeling, whichever includes Drug Facts, (where differences exist only in the quantity of contents statement) should be submitted as a JPG file. Reference ID: 4305123 NDA 21330/S021 Page 3 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, call Alina Salvatore, Regulatory Project Manager, at (240) 402-0379. Sincerely, {See appended electronic signature page} Theresa Michele, MD Director Division of Nonprescription Drug Products Office of Drug Evaluation IV Center for Drug Evaluation and Research ENCLOSURE(S): Carton and Container Labeling Reference ID: 4305123 Signature Page 1 of 1 -------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ THERESA M MICHELE 08/10/2018 Reference ID: 4305123 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: NDA 21-330/S-21 LABELING -- Data Matrix 000000)()( 4mm Drug Facts (lltle) Foot Name: NIA Drug Facts (continued) Foot Name: NIA Headings Foot Name: NIA Subheadings Foot Name: NIA Body text Foot Name: NIA BUlets Foot Name: NIA BUlels on same lines: and of stalllment sepalll!lld from bulleted Slatement by two ems NIA Spacing of the hair liles from edge of box-I.e. Mlnim1m of 2 spaces either side of Drug Fact Box NIA Trackilg NIA Horizontal Scale: NIA Leading (Mlnim1m space In body copy of Drug Faces) NIA Maxinm Chncters.tlch: NIA Balllnes NIA Hal~lnes NIA Primary Display Panel Info Font size of Net Wt/Contents (Smalest characler height ii Inches) 0.09431n. PDP dmenalons On sal.1819 lnchesl 2.4sa. In. Font size of Statement of Identity (If not Ive text, to be measured In Helvetica capital "Mi v 6pt. H NIApt. Font size of Logo/Largest Copy on PDP (II not live text, to be meastnd ii Helvetica~ "M") v 15.4 pt. H NIApt. Ratio of Statement of Identity to Logo/l...algest Copy on PDP Statement of Identity (pt.) (OMded by) Largest Logo Copy (pt.) v 38.9% H NIA% Reference ID 4305123 -- Data Matrix 000000)()( 4mm Drug Facts (lltle) Foot Name: NIA Drug Facts (continued) Foot Name: NIA Headings Foot Name: NIA Subheadings Foot Name: NIA Body text Foot Name: NIA BUlets Foot Name: NIA BUlels on same lines: and of stalllment sepalll!lld from bulleted Slatement by two ems NIA Spacing of the hair liles from edge of box-I.e. Mlnim1m of 2 spaces either side of Drug Fact Box NIA Trackilg NIA Horizontal Scale: NIA Leading (Mlnim1m space In body copy of Drug Faces) NIA Maxinm Chncters.tlch: NIA Balllnes NIA Hal~lnes NIA Primary Display Panel Info Font size of Net Wt/Contents (Smalest characler height ii Inches) 0.09431n. PDP dmenalons On sal.1819 lnchesl 2.4sa. In. Font size of Statement of Identity (If not Ive text, to be measured In Helvetica capital "Mi v 6pt. H NIApt. Font size of Logo/Largest Copy on PDP (II not live text, to be meastnd ii Helvetica~ "M") v 15.4 pt. H NIApt. Ratio of Statement of Identity to Logo/l...algest Copy on PDP Statement of Identity (pt.) (OMded by) Largest Logo Copy (pt.) v 38.9% H NIA% Reference ID 4305123 Data Matrix ­ OOOOOOXX Smm Drug Facts (rrtle) Font Name: NIA point type Drug Facts (continued) Font Name: NIA point type Headings Font Name: NIA point type Subheadings Font Name: NIA point type Body text Font Name: NIA point type Bullets Font Name: NIA point type Bullets on same lines: end of statement separated from bulleted statement by two ems NIA Spacing of the hair lines from edge of box -i.e. Minimum of 2 spaces either side of Drug Fact Box NIA Tracking NIA Horizontal Scale: NIA Leading (Minimum space in body copy of Drug Facts) NIA pt. Maximum Characters/Inch: NIA Bailines NIA pt. Hairlines NIA pt. Primary Display Panel Info Font size of Net WVContents (Smalest character height in inches) NIA in. PDP dimensions (In sauare inches) NIAsa. in. Font size of Statement of Identity (If not live text, to be measured in Helvetica capital 'Mj V N/Apt. H N/Apt. Font size of Logo/Largest Copy on PDP Of not live text, to be measured in Helvetica capital "Mi V N/Apt. H N/Apt. Ratio of Statement of Identity to Logo/Largest Copy on PDP Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.) V N/A% H NIA% Reference ID 4305123 Inside of card Outside of card, facing product coated side (coated side) Drug Facts (continued) ~// • not for sale to those under 18 years of age • lrregt.lar heartbeat or pa~ltatlons occur • proof of age required • you get symptoms of nicotine OV9rdose such as nausea, vomiting, dizziness, / • not for sale in vending machines or from any source diarrhea, wealmess and rapid heartbeat where proof of age cannot be verified • you have symptoms of an al erglc reaction (such as difflct.lty breathing or rash) Flip open Keep out of reach of children and pets. Nicotine lozenges may have enough for Directions TAMPER EVIDENT FEATURE: The lozenge container is nicotine to make chi dren and pets sick.
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