ARTICLE | Clinical News

Rytary regulatory update

September 22, 2014 7:00 AM UTC

Impax said FDA extended the PDUFA date by 3 months to Jan. 9, 2015, for a resubmitted NDA for Rytary extended-release carbidopa/levodopa for symptomatic treatment of Parkinson's disease (PD). The PDUFA date was Oct. 9. According to Impax, FDA needs time to review an amendment made to the CMC section of the NDA, which Impax had amended subsequent to its submission of responses to a Form 483 issued by the agency on July 26. FDA considered the changes a major amendment. Impax plans to submit an MAA to EMA for the product later this year. ...