Acorn Inc. receives approval for gel

BUFFALO GROVE - Akorn Inc. announced the receipt of an FDA approvable letter for Akten Ophthalmic Gel 3.5 percent, an ocular topical anesthetic drug product. The approvable letter identified several minor deficiencies that must be addressed and rectified before final approval is granted. The majority of these items have been addressed in previous submissions to the FDA. The remaining response will be submitted to the FDA within the next 10 days. No additional clinical data is required. Additionally, before approval, product labeling must be finalized. Acorn manufactures and markets sterile specialty pharmaceuticals.