AktenTreatment for Ocular Anesthesia
Update: Akten Now FDA Approved - October 7, 2008
Approvable Letter for Akten
Akorn, Inc. Receives NDA Approvable Letter for Akten Ophthalmic Gel 3.5%
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jun 4, 2008 - Akorn, Inc. 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.
Additionally, 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 ten days.
We expect Akten to be a significant revenue contributor in the second half of 2008.
About Akorn, Inc.
Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company's website at www.akorn.com.
Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.
Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results.
Arthur S. Przybyl
President and CEO
Posted: June 2008
- Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5% - October 8, 2008
- Akorn, Inc. Announces the New Drug Application Filing for Akten - June 29, 2007