The European arm of Mumbai headquartered drugmaker Sun Pharmaceuticals has decided to shelve its plans of launching the generic version of Danish company Novo Nordisk?s oral diabetes drug NovoNorm (Repaglinide) in the European market, atleast for now. The company claims that the decision to opt out has been taken keeping in mind the fact that such a move would not gel with the company?s overall marketing strategy.
The European Medicines Agency, the body that evaluates applications filed by drug companies and grants marketing approval said in a statement on Thursday, ?The European Medicines Agency has been formally notified by Sun Pharmaceutical Industries BV of its decision to withdraw its application for a centralised marketing authorisation for the medicinal product Repaglinide SUN (Repaglinide) 0.5 mg, 1 mg and 2 mg film-coated tablets.? The drug fetched Novo Nordisk revenues worth almost $500 million in 2009 and sales of the drug continue to grow in double digits (at 11%) annually. At the time when Sun Pharma sought withdrawal of its application for marketing approval, its application was being reviewed by the EMA?s Committee for Medicinal Products for Human Use. Sun Pharma had submitted its application to the European Agency for marketing approval to launch Repaglinide SUN last year in March. The European regulator had granted approval to Novo Nordisk?s original medicinal product NovoNorm in 1998. Had the company succeeded in getting a marketing approval from the European agency under the centralised procedure, it could have got the mandate to launch its product in all member states of European Union, among others.
