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Steroids, Topical Therapeutic Class Review (TCR) September 18, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. September 2020 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2020 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Manufacturer Indications Low Potency alclometasone dipropionate1 generic Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses desonide (Desonate®)2 generic, Bayer/Leo Treatment of mild to moderate atopic dermatitis in patients 3 months of age and older desonide (Desowen®)3 generic, Galderma Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses desonide (Tridesilon™)4 Encore Dermatology Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses desonide (Verdeso®)5 Almirall Treatment of mild to moderate atopic dermatitis fluocinolone acetonide Galderma Treatment of seborrheic dermatitis of the scalp (Capex® Shampoo)6 fluocinolone acetonide generic, Royal Body oil: treatment of atopic dermatitis in adults; (Derma-Smoothe-FS®)7 moderate to severe atopic dermatitis in patients 3 months and older for up to 4 weeks Scalp oil: treatment of psoriasis of the scalp in adult patients fluocinolone acetonide generic, Medimetriks Relief of inflammatory and pruritic manifestations of (Synalar®)8 corticosteroid-responsive dermatoses hydrocortisone generic, Crown, Derm Relief of inflammatory and pruritic manifestations of (Ala-Cort®, Ala-Scalp®, Anti-Itch, Ventures, Perrigo, Salix, corticosteroid-responsive dermatoses Aquanil™ HC, Beta HC, Cortaid®, Person & Covey, Beta, Cortizone-10®, CVS Anti-Itch, Valeant/Bausch, Chattem, Dermarest® Eczema, Dermolate, EQ CVS, Insight/Medtech, Anti-Itch, EQL Anti-Itch, GS Anti- Walmart, Equaline, Itch, Micort-HC, Noble Formula HC, Goodsin, Sebela, Ontos, QC Anti-Itch, RA Anti-Itch, Scalacort®, Chain Drug, Avidas, Scalp Relief, Scalpicin®, Soothing Walgreens, Reckitt, Care, Texacort™, Vanicream™)9,10,11 Mission, Pharm Spec hydrocortisone/aloe vera generic, Chattem, CVS, For the temporary relief of itching associated with (Cortizone-10®, CVS Cortisone with Walmart, Gentex/Marnel, minor skin irritations, inflammation and rashes due to Aloe, EQ-Hydrocortisone-Aloe, Chain Drug, Chattem eczema, insect bites, poison ivy, poison oak, poison Nucort™, QC Anti-Itch with Aloe, SM Cons, Sunmark sumac, soaps, detergents, cosmetics, jewelry, Hydrocortisone Plus)12,13,14 seborrheic dermatitis, psoriasis, and external anal/genital itching. Steroids, Topical Review – September 2020 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer Indications Medium Potency betamethasone dipropionate generic Relief of inflammatory and pruritic manifestations of corticosteroid- cream, lotion15,16,17 responsive dermatoses in patients 13 years and older betamethasone dipropionate Promius Treatment of mild to moderate plaque psoriasis in patients 18 years (Sernivo®)18 of age or older betamethasone valerate generic, Mylan, Relief of inflammatory and pruritic manifestations of corticosteroid- (Luxiq®)19 responsive dermatoses of the scalp betamethasone valerate20 generic Relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses clocortolone pivalate Dr. Reddy*, Relief of inflammatory and pruritic manifestations of corticosteroid- (Cloderm®)21 Promius/EPI responsive dermatoses fluocinolone acetonide generic, Relief of inflammatory and pruritic manifestations of corticosteroid- (Synalar®)22 Medimetriks responsive dermatoses flurandrenolide generic, Aqua, Relief of inflammatory and pruritic manifestations of corticosteroid- (Cordran®)23,24 Artesa responsive dermatoses flurandrenolide Allergan Relief of inflammatory and pruritic manifestations of corticosteroid- (Cordran® Tape)25 responsive dermatoses fluticasone propionate generic, Sandoz Cream, Ointment: Relief of inflammatory and pruritic manifestations (Cutivate®)26,27,28 of corticosteroid-responsive dermatoses and atopic dermatitis Lotion: Relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age and older hydrocortisone butyrate generic, Treatment of mild to moderate atopic dermatitis in patients 3 (Locoid®, Locoid Valeant/Bausch months to 18 years of age Lipocream)29,30 hydrocortisone probutate Pharmaderm/Sand Relief of inflammatory and pruritic manifestations of corticosteroid- (Pandel®)31 responsive dermatoses in patients 18 years of age and older hydrocortisone valerate32 generic Relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses in adult patients mometasone furoate33 generic Relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses in patients 2 years of age or older prednicarbate generic, Relief of the inflammatory and pruritic manifestations of (Dermatop®)34 Valeant/Bausch corticosteroid responsive dermatoses triamcinolone acetonide generic, Promius, Relief of inflammatory and pruritic manifestations of corticosteroid- (Dermasorb™ TA, Kenalog®, Ranbaxy/Sun, responsive dermatoses Trianex®)35,36,37 Crown Labs, Upsher-Smith * Available as authorized generic (AG). Steroids, Topical Review – September 2020 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer Indications High Potency amcinonide38 generic Relief of inflammatory and pruritic manifestations of betamethasone dipropionate generic corticosteroid-responsive dermatoses in patients 13 years and ointment39,40 older betamethasone dipropionate generic augmented cream41,42 clobetasol propionate Encore/Promius Treatment of moderate to severe plaque psoriasis in patients 18 (Impoyz™)43 years of age and older desoximetasone generic, Taro Relief of inflammatory and pruritic manifestations of (Topicort®)44,45 corticosteroid-responsive dermatoses diflorasone diacetate cream Sandoz, Taro (Apexicon® E, Psorcon®)46,47 Fluocinonide (Vanos) are indicated for use in patients 12 years and older fluocinonide48 generic 49 fluocinonide (Vanos®) generic ,Valeant/Bausch Topicort topical spray is only approved for treatment of plaque halcinonide (Halog®)50,51 generic, Ranbaxy/Sun psoriasis in patients 18 years of age or older triamcinolone acetonide52,53 generic, Crown Labs Steroids, Topical Review – September 2020 Page 4 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer Indications Very High Potency betamethasone dipropionate generic, Merck Relief of inflammatory and pruritic manifestations of corticosteroid- augmented gel, lotion, responsive dermatoses in patients 13 years of age and older. ointment (Diprolene)54,55,56 clobetasol propionate generic, Galderma, Lotion: Relief of inflammatory and pruritic manifestations of (Clobex®, Clodan™) 57,58 Medimetrix, corticosteroid-responsive dermatoses Shampoo: Treatment of moderate to severe forms of scalp psoriasis Spray: Treatment of moderate to severe plaque psoriasis affecting up to 20% of body surface area clobetasol propionate generic, Sandoz, Cream, emollient, gel, ointment: Short-term treatment of (Cormax®, Temovate®)59,60,61 Valeant inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses Solution: Short-term treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp clobetasol propionate Mylan Specialty Relief of the inflammatory and pruritic manifestations of (Impeklo™)62 corticosteroid-responsive dermatoses in patients 18 years of age or older clobetasol propionate generic, Short-term treatment of inflammatory and pruritic manifestations of (Olux®, Olux-E®)63 Prestium/Mylan corticosteroid-responsive
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  • Medical Review~ Clinical Review

    Medical Review~ Clinical Review

    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 21-978 MEDICAL REVIEW~ CLINICAL REVIEW Application Type NDA Submission Number 21-978 Submission Code 000 Letter Date November 18, 2005 Stamp Date November 28, 2005 PDUFA Goal Date September 21,2006 Reviewer Name Denise Cook, M.D. Review Completion Date 8/28/06 Established Name Desonide (Proposed) Trade Name .. Therapeutic Class Topical corticosteroid Applicant Connectics Priority Designatiop S Formulation Foam, 0.05% Dosing Regimen bid Indication F or the treatment of mild to moderate atopic dermatitis . Intended Population Age 3 months and above Clinical Review Denise Cook, M.D. NDA 21-978/ N-OOO _ loam, 0.05%/desonide foam, 0.05% Table of Contents 1 EXECUTIVE SUMMARy................................................................................................................................5 1.1 RECOMMENDATION ON REGULATORY ACTION ...........................................................................................5 1 .2 RECOMMENDATION ON POSTMARKETING ACTIONS. .............. ...... .... .... ........... ........ ..... ... ..... ...... ......... ........5 1.2. I Risk Management Activity................ ......... ..... ............... ..... ................... ........ ........ .... ....... ... ......... ........5 1.2.2 Required Phase 4 Commitments............................................................................................................5 1.2.3 Other Phase 4 Requests..........................................................................................................................5