News from the US FDA

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    22-Mar-2017

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  • 22 MARKET NEWS

    News from the US FDA The oral retinoid acitretin [Soriatane] has been

    unanimously recommended for approval for the treatment of severe, recalcitrant psoriasis by the FDA's Dermatologic Advisory Committee.

    Roche said that acitretin will replace their currently marketed retinoid etretinate [Tegosin@]. The committee agreed that acitretin showed a superior pharmacokinetic profile and comparable efficacy to etretinate.

    Acitretin is eliminated much more rapidly than etretinate, which increases its safety, but acitretin is converted to etretinate when alcohol is consumed. Consequently, the committee would like to see the same precautions, contraindications and warnings included in acitretin's labelling as are included in etretinate's.

    Roche said that treatment with acitretin should be individualised, and because of its greater safety, the company hopes that acitretin will not have the same restricted indication as etretinate - treatment for those who are unresponsive to or intolerant of standard therapies. Roche believes that acitretin is in fact the treatment of choice in erythrodermic and pustular psoriasis and may be safer than other options in certain situations.

    Acitretin was approved in its first market in 1988 and is marketed in 16 countries.

    A prescription to over-the-counter status change for Johnson & Johnson's ketoconazole 1 % dandruff shampoo also got a unanimous recommendation for approval by FDA committees.

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    5 Mar 1994 INPHARMAe 0156-2703l941092H)OO22l$1.00C Adls Internatlpnal Limited 1994. All rights reserved