Successful development and approval of Skinatan® 1 mg/g Emulsion – a new generic drug for the treatment of inflammations and allergic reactions

Successful development and approval of Skinatan® 1 mg/g Emulsion – a new generic drug for the treatment of inflammations and allergic reactions

24. September 2021 0

Skin Care Pharma GmbH, a company of Dermago Verwaltungs GmbH, announces that yet another milestone has been reached in the development and approval of Skinatan® 1 mg/g Emulsion for cutaneous application with the active ingredient methylprednisolone aceponate (MPA). Upon receipt of the “End of Procedure” notification, the decentralized procedure (DCP) for Skinatan® 1 mg/g Emulsion has been successfully completed for six European member states. Within the next few weeks, Skin Care Pharma GmbH and its license partners are to be granted marketing approval for Skinatan® 1 mg/g Emulsion by the respective national authorities.

 Skinatan® 1 mg/g Emulsion is a dermatological milk for cutaneous use with the active ingredient methylprednisolone aceponate (MPA). MPA belongs to the latest generation of topical glucocorticoids, characterized by a favourable therapeutic index i.e. a positive ratio of effect and side effect.

Skinatan® is a generic version of Advantan®. Advantan® is approved and available in more than 60 countries world-wide with an annual turnover in excess of $100m.

Advantan® Milk 0.1% Emulsion for cutaneous use is approved among others for acute treatment of mild to moderate skin rashes (eczemas), such as allergic reactions, nummular eczema, dyshidrotic eczema, nonspecific skin rash, and atopic dermatitis or neurodermatitis or scaly and reddened skin rash (seborrheic eczema).

Skin Care Pharma GmbH

Skin Care Pharma GmbH was founded by Sven Schimansky-Wabra in 2012. Skin Care Pharma GmbH specializes in the development of semi-solid pharmaceuticals as generic versions. In 2016, the German regulatory authority BfArM officially confirmed the formulation of the generic Skinatan® pharmaceuticals in four different topical dosage forms (solution, emulsion, cream and ointment).

As early as 2020, Skinatan® 1 mg/ml Solution for cutaneous application was successfully developed and approved. In Germany, the latter is marketed by the partner GALENpharma GmbH under MetiGalen®. This is followed suit by the approval of Skinatan® 1 mg/g Emulsion for cutaneous application. For the further development of Skinatan® Cream and Ointment, Skin Care Pharma GmbH was able to successfully complete two pivotal clinical studies and has already applied for marketing approval of both formulations in seven European countries by means of a decentralized procedure (DCP).

 


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