The approvable letter identified several minor CMC deficiencies that must be addressed and rectified before final approval is granted. The majority of these items have been addressed in the company’s previous submissions to the FDA. The remaining response will be submitted to the FDA within the next ten days.
Additionally, prior to approval, product labeling must be finalized. The company said that it received proposed labeling from the FDA and will submit final printed labeling within the next ten days.