Novartis' Zelmac OKed in Switzerland

Novartis has been granted marketing approval for its irritable bowelsyndrome drug Zelmac (tegaserod) in Switzerland, paving the way for its registration in up to 70 additional countries in areas such as Asia Pacific and Latin America. The drug was first launched in Mexico and is now available in six countries, despite being held up by the US and European Union regulatory authorities (Marketletters passim).

At an R&D meeting held on October 30 (more details next week), Novartis noted that an expert assessment of the drug, which addressed issues raised by regulators on its safety and efficacy, has come out in favor of Zelmac's profile, and this analysis has been submitted to the US Food and Drug Administration as part of an appeal. In the EU, new clinical trials are expected to start in early 2002, said the firm.