Rytary regulatory update

Impax said FDA issued a complete response letter for an NDA for Rytary extended-release carbidopa/levodopa to treat idiopathic Parkinson's disease (PD). According to the company, the agency is requiring a "satisfactory re-inspection" of Impax's Hayward, Calif., manufacturing facility. In 2011, Impax received a warning letter from FDA for the facility citing cGMP violations; the company subsequently withdrew the facility as an alternative site for commercial production during the NDA review. Impax said FDA is requiring a satisfactory inspection because of the "facility's involvement in the development of Rytary," as well as its "supportive manufacturing and distribution activities." The company said it plans to work with FDA on appropriate next steps.

From late June 2011 to the end of 2011, Impax submitted a response to FDA's warning letter, and the agency completed a re-inspection of the facility in 1Q12 in connection with the warning letter and as a general GMP inspection. As a result of the general GMP inspection, FDA issued a Form 483, with observation primarily relating to its quality control laboratory. The company declined to disclose details. ...