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KFDA to withhold Iressa registration.

Published: 2003-06-05 20:14:00
Updated: 2003-06-05 20:14:00
The KFDA withheld the health registration of Iressa, an anti-cancer drug for a non-small cell lung cancer, filed by AstraZeneca Korea, claiming that the required dissolution test data and its related results were not sufficient enough to draw any conclusion.

Accordingly, AstraZeneca should submit the data covering the dissolution test results to the KFDA.

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