Sun Pharmaceutical Industries withdrew its marketing authorisation application for Topotecan SUN on 17 February 2011. EMA was formally notified by Sun of its decision to withdraw its application for a centralised marketing authorisation for the medicinal product Topotecan SUN 1 mg and 4 mg powder for concentrate for solution for infusion.
Topotecan market too hot for Sun
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Posted 15/04/2011
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In its official letter, Sun stated that it had decided to discontinue the application because, due to the number of competitors, it no longer had a commercial interest in the product.
The application for the marketing authorisation for Topotecan SUN was submitted to EMA on 1 November 2010. At the time of the withdrawal, it was under review by the EMA’s Committee for Medicinal Products for Human Use.
The medicine was developed as a generic medicine to be used for the treatment of metastatic cancer of the ovary, small cell lung cancer and cervical cancer. The reference medicinal product for Topotecan SUN is Hycamtin, which has been authorised in the EU since 1996 and is marketed by GlaxoSmithKline.
Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.
Source: EMA
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