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209269Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209269Orig1s000 OTHER REVIEW(S) FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research Office of Prescription Drug Promotion ****Pre-decisional Agency Information**** Memorandum Date: April 18, 2017 To: Belainesh Robnett Regulatory Project Manager Division of Dermatology and Dental Products (DDDP) From: Matthew J. Falter, Pharm.D. Team Leader Office of Prescription Drug Promotion (OPDP) CC: Silvia Wanis, Pharm.D., CPH Regulatory Review Officer, OPDP Subject: NDA 209269 Addendum to OPDP labeling comments for MINOLIRA™ (minocycline hydrochloride) extended-release tablets, for oral use Reference is made to DDDP’s July 18, 2016, consult request for OPDP’s comments regarding the proposed Package Insert (PI) and Carton and Container Labeling for MINOLIRA™ (minocycline hydrochloride) extended-release tablets, for oral use (Minolira). Addition reference is made to OPDP’s review of the proposed Minolira PI and Carton and Container labeling checked into DARRTS on March 29, 2017. Further reference is made to the sponsor’s proposed revisions to the PI submitted by the sponsor on April 12, 2017, and located in SharePoint on April 18, 2017. Reference is also made to the proposed revisions to the Carton and Container labeling submitted to FDA on April 12, 2017 and located in the EDR at: \\cdsesub1\evsprod\nda209269\0015\m1\us\114-label\1141-draft- label\contain-135mg-ps-10count.pdf \\cdsesub1\evsprod\nda209269\0015\m1\us\114-label\1141-draft- label\contain-135mg-30count.pdf 1 Reference ID: 4085718 \\cdsesub1\evsprod\nda209269\0015\m1\us\114-label\1141-draft- label\contain-105mg-ps-10count.pdf \\cdsesub1\evsprod\nda209269\0015\m1\us\114-label\1141-draft- label\contain-105mg-30count.pdf This addendum serves as review of the aforementioned documents. OPDP has reviewed the proposed revisions to the PI and has no comments at this time. OPDP has also reviewed the proposed revisions to the Carton and Container labeling and offers the following comments. OPDP is concerned that the proposed trade dress in the Carton and Container labeling is promotional in tone and may give a misleading impression regarding the efficacy of Minolira. We note that the tittle over the first ‘i’ in the proprietary name is large and prominent but then as a circular pattern is created, becomes smaller, faint, and nearly imperceptible. This presentation may misleadingly suggest that as a result of using Minolira for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris, all patients will achieve similar improvements in inflammatory lesions, when this is not the case. According to the draft PI, the mean percent improvement in inflammatory lesions in subjects treated with Minolira was 43-46%. In addition, only 16-17% of subjects were evaluated as either clear or almost clear on the Evaluator’s Global Severity Assessment. The graphical presentation in the trade dress of the proposed proprietary suggests a greater improvement in inflammatory lesions than what has been demonstrated, which may be misleading. We remind the sponsor that labeling must not be promotional in tone nor false or misleading in any particular. Therefore, we recommend deleting the graphical presentation over the first ‘i’ in the trade dress of the proprietary name. Thank you for the opportunity to review the revised PI and Carton and Container labeling. If you have any questions, please contact me at [email protected] or 6-2287. 4 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS) immediately following this page 2 Reference ID: 4085718 --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- MATTHEW J FALTER 04/18/2017 Reference ID: 4085718 MEMORANDUM REVIEW OF REVISED LABEL AND LABELING Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) Date of This Memorandum: April 13, 2017 Requesting Office or Division: Division of Dermatology and Dental Products (DDDP) Application Type and Number: NDA 209269 Product Name and Strength: Minolira (minocycline hydrochloride) extended release tablets, 105 mg and 135 mg Applicant/Sponsor Name: Dr. Reddy’s Laboratories, Inc. Submission Date: April 12, 2017 OSE RCM #: 2016-1634-1 DMEPA Primary Reviewer: Madhuri R. Patel, Pharm.D. DMEPA Team Leader (Acting): Sarah K. Vee, PharmD 1 PURPOSE OF MEMO The Division of Dermatology and Dental Products (DDDP) requested that we review the revised container labels, Prescribing Information (PI), and Instructions for Breaking Tablets for Minolira (minocycline hydrochloride) extended release tablets (NDA 209269) (Appendix A) to determine if it is acceptable from a medication error perspective. The revisions are in response to recommendations that we made during a previous label and labeling review.a 2 CONCLUSION The revised Prescribing Information (PI) and Instructions for Breaking Tablets is acceptable from a medication error perspective. However, the revised container labels are unacceptable from a medication error perspective. We note the established name is not at least half the size of the proprietary name, which could increase the risk for medication errors. Therefore, we provide a recommendation in Section 4 for the Applicant to address this concern. 3 RECOMMENDATIONS FOR DR. REDDY’S LABORATORIES, INC. a Patel M. Label and Labeling Review for MINOLIRA (NDA 209269). Silver Spring (MD): FDA, CDER, OSE, DMEPA (US); 2017 FEB 13. RCM No.: 2016-1634. 1 Reference ID: 4084019 We recommend the following be implemented prior to approval of this NDA 209269: A. Container Label: The established name is not at least half the size of the proprietary name. Thus, we request you revise the established name to be in accordance with 21 CFR 201.10(g)(2). 1 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS) immediately following this page 2 Reference ID: 4084019 --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- MADHURI R PATEL 04/14/2017 SARAH K VEE 04/14/2017 Reference ID: 4084019 Materials Reviewed • The Labeling Review Tool Draft Guidance for Industry and Review Staff - Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice for Industry and Review Staff Products Labeling Good Review Practice 1 • The February 2013 Draft Guidance for Industry and Review Staff: Pediatric Information Incorporated into Human Prescription Drug and Biological Products Labeling 2 • Applicant’s submitted background package and proposed package labeling for MINOLIRA minocycline hydrochloride (HCl) extended release tablets, NDA 209269 • DPMH Pregnancy and Lactation Labeling Review dated February 17, 2017; DARRTS Reference ID 3966934 • Solodyn (minocycline HCL) ER tablets Label Drugs@FDA, accessed February 2, 2017 • DPMH Pregnancy and Lactation Labeling Review dated 02/12/17 Reference ID: 4056229 accessed February 22, 2017 • Reviewer Literature Search using Embase and PubMed databases; Search terms “minocycline and tooth discoloration” “minocycline and tooth staining” Consult Request DDDP consulted DPMH on January 24, 2017 to provide input for appropriate format and content of the Pediatric Use section of MINOLIRA (minocycline HCl) extended-release (ER) labeling. I. Background MINOLIRATM (minocycline HCl) ER tablets are a semi-synthetic derivative of tetracycline. 3 The mechanism of action and pharmacodynamics of MINOLIRA in the treatment of acne are (b) (4) unknown. MINOLIRA is supplied as scored tablets containing minocycline hydrochloride equivalent to 105 milligrams (mg) and 135 mg of minocycline. 3 Minocin (minocycline HCl) was originally approved on June 30, 19714 as 100 mg capsules for treatment of infections due to susceptible strains of micro-organisms. Labeling at that time also stated tetracyclines may be useful adjunctive therapy in severe acne. Minocycline HCl is 1http://inside.fda.gov:9003/CDER/OfficeofNewDrugs/ImmediateOffice/LabelingDevelopmentTeam/ucm025576.ht m accessed 2 February 2017 2 http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm341394.pdf accessed November 1, 2016 3 Applicant’s submitted background package and proposed package labeling for MINOLORA [minocycline hydrochloride (HCL) extended release tablets, NDA 209269 4 1971 FDA Approved package retrieved 03/01/17 search of PharmaPendium for Minocin https://www.pharmapendium.com/#/browse/fda/Minocycline%20Hydrochloride/365a8b82452ccaf6e2d3cca1848abd 2e?query=Minocin&includeSynonyms=true Page 2 of 19 Reference ID: 4079085 currently approved in various dosage forms (immediate-release capsule, extended-release capsule, microspheres, and injectable) for treatment of bacterial infections,
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