FDA Accused Of Cutting Obesity Drug's Exclusivity Short

Law360, New York (August 13, 2013, 3:54 PM EDT) -- Eisai Co. Ltd. on Friday accused the U.S. Food and Drug Administration of unfairly shortening its five-year exclusivity period for obesity drug Belviq by starting the clock when approval came through, despite sales of the medicine not being allowed for another year.

In a citizen petition released Friday, Japan-based Eisai said the FDA had viewed the exclusivity period as commencing when it cleared Belviq in June 2012, even though the company wasn’t allowed to market the product because required scheduling by the U.S. Drug Enforcement Administration...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.