Rytary regulatory update
In January, FDA issued a complete response letter for an NDA for Rytary treat idiopathic PD. According to the company, the agency is requiring a "satisfactory re-inspection" of the Hayward facility (see BioCentury, Jan. 28). Impax said that analytical method validation and a portion of the stability data for Rytary were generated at the facility. The company said it now plans for a 2014 launch of Rytary.
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. 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 observations primarily relating to its quality control laboratory. ...