BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Akorn, Inc. (NASDAQ: AKRX) today announced the receipt of an FDA approvable letter for Akten® Ophthalmic Gel 3.5%, an ocular topical anesthetic drug product. Our 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 our previous submissions to the FDA. The remaining response will be submitted to the FDA within the next ten days. No additional clinical data is required.
