Monday, April 11, 2011

ANDA APPROVAL TIMELINES

The time required to obtain FDA approval of ANDAs has increased over the last three years from an industry-wide average of approximately 19 months after initial filing in 2007 to an industry-wide average of approximately 31 months after initial filing in 2010. In addition, the aggregate number of ANDAs pending review by the FDA was over 2,000 as of December 31, 2010. These long approval times favor companies who can prepare high-quality ANDA submissions and who maintain on-going dialogue and strong relationships with regulatory agencies.