Femara - an aromatase inhibitor - is known to be submitted and currently under a review by the Japanese regulatory authorities. Yet, as distributed today by the mass media, the warnings issued by Novartis AG were forwarded to the physicians in Japan as well. As read between the lines - under the provision of the Pharmaceutical Affairs Law (PAL), any unapproved drug could be imported for individual use in Japan as long as the custom official is shown a prescription by Japanese doctor. Obviously, Femara (the name is misspelled in the original news release below) - another of the unapproved anti-cancer drugs in Japan has been imported by significant number of female patients treated domestically.
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Technorati Tags: MHLW; Japanese regulatory affairs
TOKYO — A Swiss pharmaceutical company has decided to warn gynecologists in the United States, Japan and other countries not to prescribe women a breast cancer drug during pregnancy or before menopause, as it may harm unborn children, officials of the its Japanese associate said Wednesday.