Akorn receives approvable letter for ophthalmic gel

Buffalo Grove, IL-Akorn Inc. has received an FDA approvable letter for an ocular topical anesthetic 3.5% (Akten Ophthalmic Gel).

The letter identified several minor deficiencies that have been addressed in previous submissions, according to the company, and the deficiencies need to be rectified before final approval is granted.

No additional clinical data were required for the remaining response submitted to the FDA.

The drug is expected to be a “significant revenue contributor” in the second half of 2008, according to a prepared statement issued by Akorn.