16:27 , Aug 18, 2017 |  BC Week In Review  |  Clinical News

FDA approves Abilify for bipolar disorder

H. Lundbeck A/S (CSE:LUN) and Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said FDA approved an sNDA for once-monthly Abilify Maintena aripiprazole to treat bipolar I disorder. Abilify Maintena is already approved to treat schizophrenia. The product...
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
00:29 , Dec 2, 2016 |  BC Week In Review  |  Clinical News

Abilify Maintena regulatory update

H. Lundbeck and Otsuka said FDA accepted for review an sNDA for once-monthly Abilify Maintena aripiprazole to treat bipolar I disorder. The PDUFA date is July 28, 2017. Abilify Maintena is approved to treat schizophrenia....
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Abilify Maintena once-monthly aripiprazole regulatory update

FDA issued a drug safety communication warning that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of the antipsychotic drug aripiprazole. FDA said the uncontrollable...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Aristada aripiprazole lauroxil regulatory update

FDA issued a drug safety communication warning that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of the antipsychotic drug aripiprazole. FDA said the uncontrollable...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Abilify aripiprazole regulatory update

FDA issued a drug safety communication warning that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of the antipsychotic drug aripiprazole. FDA said the uncontrollable...
07:00 , Oct 12, 2015 |  BC Week In Review  |  Clinical News

Aristada aripiprazole lauroxil regulatory update

FDA approved Aristada aripiprazole lauroxil from Alkermes to treat schizophrenia. The company plans to launch the injectable, extended-release formulation of aripiprazole using LinkeRx technology “immediately.” Alkermes said the product is the first atypical antipsychotic with...
01:19 , Oct 7, 2015 |  BC Extra  |  Company News

FDA denies Otsuka petition, approves Alkermes' Aristada

Alkermes plc (NASDAQ:ALKS) fell $1.27 to $58.50 amid a wider biotech sell-off on Tuesday, a day after FDA approved the company's Aristada aripiprazole lauroxil to treat schizophrenia. The drug is an injectable, extended-release formulation of...
01:29 , Oct 6, 2015 |  BC Extra  |  Company News

FDA approves Alkermes' Aristada

Alkermes plc (NASDAQ:ALKS) gained $3.73 to $63.50 in after-hours trading after it said FDA approved Aristada aripiprazole lauroxil to treat schizophrenia. The company said it is preparing to launch Aristada "immediately." Alkermes spokesperson Kathryn Morris...
07:00 , Sep 7, 2015 |  BC Week In Review  |  Clinical News

Aristada aripiprazole lauroxil regulatory update

Alkermes said FDA will not be able to complete the review of the biotech’s NDA for Aristada aripiprazole lauroxil to treat schizophrenia by the Aug. 22 PDUFA date. The company said FDA indicated the delay...