FDA "approvable" letter for Akorn's Akten

Akorn says it has received a Food and Drug Administration "approvable" letter for Akten Ophthalmic Gel 3.5%, an ocular topical anesthetic drug product. This identified several minor CMC deficiencies that must be addressed and rectified before final approval is granted, the firm said. "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," it noted.

Additionally, said Akonr, "prior to approval, product labeling must be finalized. We have received proposed labeling from the FDA and will submit final printed labeling within the next 10 days. We expect Akten to be a significant revenue contributor in the second half of 2008."