Eisai Company, Ltd. Sues The FDA To Regain "Lost" Marketing Time For Its Drugs
Published: Aug 18, 2014
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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