AusPAR: Clobetasol propionate - Therapeutic Goods Administration

Therapeutic Goods AdministrationI. Introduction to product submissionSubmission detailsType of Submission:New Chemical EntityDecision:ApprovedDate of Decision: 6 February 2013Active ingredient:Product Name:Sponsor’s Name and Address:Dose form:Strength:Container(s):Pack size:Approved Therapeutic use:Route of administration:Dosage:Clobetasol propionateClobexGalderma Australia Pty Ltd13B Narabang WayBelrose NSW 2085Shampoo500 μg/gBottle4, 8 or 16 doses of 7.5 mL (30, 60 and 125 mL bottles)Topical treatment of moderate to severe scalp psoriasis in adults.Topical3.75 mg (7.5 mL) once dailyARTG Number: 188346Product backgroundThis AusPAR describes the application by Galderma Australia Pty Ltd to register a newchemical entity, clobetasol proprionate (0.05%; 500 µg/g; Clobex), originally as both aspray or shampoo formulation for the topical treatment of moderate to severe plaque-typeor scalp psoriasis, respectively. The application to register Clobex topical spray solutionwas withdrawn by the sponsor on the 23 of October 2012. Thus, this document will notrefer to the spray submission.Clobetasol propionate (CP) bears structural similarity to other betamethasone-typecorticosteroids including betamethasone, dexamethasone and fluocortolone. Clobetasolpropionate (CP) was previously registered on the Australian Register for TherapeuticGoods (ARTG) as Dermovate. This range has been delisted from the ARTG so, as advised bythe TGA, in this proposed application,clobetasol-17-propionate will be classified as a newchemical entity (NCE). It has been marketed overseas (USA and Europe) for over 20-30years and has been widely available for topical administration at a concentration of 0.05%in several dosage forms (including ointment, cream, solution and gel) for use ininflammatory diseases.The sponsor requested the following indications:AusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5Final 22 May 2013Page 5 of 45