Zotepine Filing With EMEA This Month?

7 July 1996

Knoll's atypical antipsychotic zotepine is set for more wide-spread use, now that the company has decided to pursue European Union-wide approval through the European Medicines Evaluation Agency.

A spokesman for the company told the Marketletter that zotepine was recently introduced in Austria, and has also been available in Germany since 1990. The drug was originated by Fujisawa of Japan, where it has been on the market since 1982. The spokesman said that the company had not yet made a decision on how it would approach the US market for zotepine.

Knoll believes that zotepine will be popular with physicians because of the long-term experience with the compound in Japan. Like other atypical antipsychotics, zotepine is associated with a low incidence of extrapyramidal side effects. In particular, the drug has not been associated with tardive dyskinesia.

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