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Eisai Company, Ltd. (ESALY.PK) Sues The FDA To Regain "Lost" Marketing Time For Its Drugs



8/18/2014 6:14:23 AM

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Twice over the past two years, Eisai won FDA approval for new drugs and the endorsements triggered an important five-year period in which generic competition could be kept at bay.

But Eisai quickly ran into delays launching its drugs. Both of its medicines – the Belviq diet pill and the Fycompa epilepsy treatment – are controlled substances. And this meant these could not be marketed until the U.S. Drug Enforcement Agency placed them on lists of drugs for which distribution is restricted.

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