Main Category: Allergy
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Oct 2011 - 6:00 PDT
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Krka, d.d., Novo mesto formally notified The European Medicines Agency after deciding to withdraw their application for the centralized marketing authorization for Desloratadine Krka (desloratadine), 5 mg film coated tablets, intended to relief symptoms linked to allergic rhinitis and urticaria due to changes in the company's marketing strategy. The medication is a generic of Aerius, which has been authorized in Europe since 15 January 2001.
The initial application for Desloratadine Krka's marketing authorization was submitted on the 3 February 2011, after receiving a positive review by the Committee for Medicinal Products for Human Use (CHMP) on 22 September 2011. In their official letter the company stated that its decision to withdraw is due to changes in their marketing strategies. Desloratadine Krka was awaiting marketing authorization by the European commission at the time of withdrawal.
More information regarding Desloratadine Krka will be published on the Agency's website after the CHMP meeting on 14-17 November 2011. The information contains a question-and-answer document together with the assessment report and the company's withdrawal letter.
Withdrawing an application does not forfeit the possibility of making a new application at a later stage.
Written by Petra Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
MLA
8 Dec. 2011.
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