FDA will grant a shelf life period of two times the available long-term data at
the time of approval (up to 24 months) following the recommendation of the
ICH Q1E Evaluation of Stability Data (ICH Q1E) guidance,7 provided the
submitted data are satisfactory, and data evaluation and appropriate
commitments are provided in accordance with ICH Q1E. Please refer to the
decision tree (Appendix A) in ICH Q1E. The ANDA should be updated with
12 months of long-term data during the review cycle.
