Schizophrenia.com, paranoid schizophrenia - Schizophrenia News, schizophrenia treatment, Abilify

l; charset=iso-8859-1">

Home | About | Donate/Volunteer | C = "width=" + width +","; window.popupWindow = open( url, "popup_window", hstr + wstr +"screenX=250," +"screenY=50," +"resizable=yes," +"scrollbars=yes," +"status=no," +"toolbar=no," +"directories=no," +"menubar=no" ); popupWindow.focus(); }

Home | About | Donate/Volunteer | Contact | Jobs

Otsuka schizophrenia drug runs FDA gauntlet

September, 2002

The FDA is nearing approval on a schizophrenia drug developed by Rockville-based Otsuka America Pharmaceutical.

Otsuka, which was founded in Japan in 1921, received an "approvable" letter from the Food and Drug Administration Aug. 29, after the bioscience company submitted data on its drug, Abilify, following the conclusion of phase III clinical trials.

Abilify's final approval is contingent upon the completion of ongoing discussions between Otsuka and the FDA.

"We still have a few issues that we have to address with the FDA," says Wayne Laslie, executive vice president of sales and marketing for Otsuka America.

Even so, Laslie says, the letter has given the company some confidence that Abilify will make it to market as a successful anti-psychotic. Otsuka estimates the U.S. market for anti-psychotic drugs is $5 billion annually. Schizophrenia affects about 2.2 million Americans.

An Introduction to Schizophrenia

General Schizophrenia Information