Akorn announced that the FDA has approved its topical eye anesthetic Akten. And the developer says this is the first new FDA approval of an ocular anesthetic in 40 years. The company says it will launch later this month. Akorn had planned on a second quarter launch but was delayed by discussions with the agency on manufacturing issues.
Abu Alam, Ph.D., Akorn's Senior Vice President of New Business Development stated, "The robust data from the multi-center clinical trial with respect to rapid onset and extended duration of anesthesia will be ideally suited for many ophthalmic procedures in both hospital and office based surgical setting.
- read the Akorn release
[1]- check out the AP report [2]
ALSO: Dr. Reddy's has won final approval to market its anti-convulsant drug Primidone. Report [3]
Related Articles:
Akorn anesthesia hits endpoints in Phase III [4] (Jan 2007)
Akorn and India's Natco Pharma enter agreement [5] (Nov. 2006)
Akorn inks pact with Sofgen [6] (Aug. 2006)
Akorn inks manufacturing pact with GeneraMedix [7] (Aug 2006)
Links:
[1] http://www.fiercebiotech.com/press-releases/akorn-inc-announces-fda-approval-akten-ophthalmic-gel-3-5
[2] http://www.forbes.com/feeds/ap/2008/10/08/ap5524252.html
[3] http://www.myiris.com/newsCentre/newsPopup.php?fileR=20081008125046198&dir=2008/10/08&secID=livenews
[4] http://www.fiercebiotech.com/story/akorn-anesthesia-hits-endpoints-in-phase-iii/2007-01-23
[5] http://www.fiercebiotech.com/story/also-noted-bronchitol-gains-fast-track-alimera-garners-15.9m-in-second-tran/2006-11-27
[6] http://www.fiercebiotech.com/story/also-noted-akorn-inks-pact-with-sofgen-new-cancer-start-up-and-much-more/2006-08-10
[7] http://www.fiercebiotech.com/story/also-noted-sankyo-gains-rights-to-diabetes-drug-ligand-slashes-interim-ceo-/2006-08-31