CEPH gets Nuvigil approvable letter
Cephalon (CEPH) received an approvable letter from FDA for Nuvigil armodafinil to treat excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. The company said that approval is contingent upon finalizing the product label and that additional studies are not required.
Nuvigil is a longer-acting, single isomer of CEPH's Provigil modafinil, which is marketed for the same indications and is under review for ADHD under the brand name Sparlon. In the Nuvigil approvable letter, the agency said the product's label will reflect the agency's review of information related to a possible case of Steven Johnson's Syndrome (SJS) associated with Sparlon. FDA recently extended the PDUFA date for Sparlon to Aug. 22 to review the information, which the company submitted last month. ...