Further relief for Merck & Co's Mevacor

Merck & Co has noted that the US District Court in Washington hasextended for 10 days its temporary restraining order on the US Food and Drug Administration's decision to deny the company's application for pediatric exclusivity for the lipid-lowerer Mevacor (lovastatin; Marketletter June 25). A trial on the merits of the case is scheduled for July 3.

The initial stay was granted on June 16, after the FDA denied Merck's request to get an additional six months of US marketing exclusivity for Mevacor on the basis of pediatric studies it conducted at the request of the agency. Meantime, a number of companies have already received approval from the FDA to launch generic lovastatin.