Ocular topical anesthetic drug moves through the pipeline

June 6, 2008

An ocular topical anesthetic drug (Akten, Akorn Inc.) has received an FDA approvable letter. The letter identified minor CMC deficiencies that must be rectified before approval is granted.

Buffalo Grove, IL-An ocular topical anesthetic drug (Akten, Akorn Inc.) has received an FDA approvable letter. The letter identified several minor CMC deficiencies that must be rectified before final approval is granted, according to the company.

Most of these items have been addressed in the company's previous submissions to the FDA, and the remaining responses will be submitted to the FDA later this month. No additional clinical data are needed, the company added.

Before the approval process is complete, product labeling must be finalized. Proposed labeling has been received by the FDA and final printed labeling will be submitted this month.