Eisai wants FDA to amend exclusivity date for two drugs

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) said FDA erred by starting the five-year exclusivity period for obesity drug Belviq lorcaserin and epilepsy drug Fycompa perampanel before the pharma was able to begin "commercial marketing" of the drugs, according to a (see BioCentury Extra, June 7).

FDA regulations define the date of approval for exclusivity purposes as the date an NDA is approved so long as the agency does not need to approve labeling or other materials. For drugs subject to DEA scheduling, FDA must approve labeling that incorporates the final scheduling before a company can commercially market the drug. As a result, Eisai said the exclusivity period should be "triggered only when FDA approved labeling incorporating the final schedule permits commercial marketing of the products." ...