Cubicin daptomycin regulatory update

Cubist submitted a Citizen's Petition to FDA asking the agency to not approve ANDAs for generic versions of the company's antibiotic Cubicin daptomycin. The petition, filed Dec. 3, asks FDA to require applicants to demonstrate comparability to Cubicin using microbiological potency and chemical and in vivo testing; demonstrate that it monitors and controls for impurities; and demonstrate the comparability of its generic with commonly used infusion systems and plastic syringes to prevent leaching of potential extractables. Cubist's U.S. patents for Cubicin begin to expire in 2016. ...