FierceBiotech

PRESS RELEASE: FDA Approves Otsuka Pharmaceutical and Bristol-Myers Squibb's ABILIFY for Adolescent Patients With Schizophrenia

TOKYO and PRINCETON, N.J., Nov. 6 -- Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY - News) announced today that the U.S. Food and Drug Administration (FDA) approved the ...
EurekAlert!

ABILIFY approved for acute treatment of bipolar I disorder in patients 10 to 17 years old

ABILIFY was initiated at a starting dose of 2 mg/day and titrated to the target dose of 10 mg/day or 30 mg/day. The primary efficacy endpoint was the mean change in the Y-MRS Total Score from baseline ...
Business Wire

Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application for Aripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizophrenia and Bipolar I ...

If approved, aripiprazole 2-month ready-to-use (RTU), long-acting injectable (LAI) would be the first 2-month, LAI antipsychotic indicated for both treatment of schizophrenia and the maintenance ...
Business Wire

ABILIFY® (Aripiprazole) Injection for Intramuscular Use for Adults With Agitation Associated With Schizophrenia or Bipolar Mania Now Available

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. today announced the launch of ABILIFY® (aripiprazole) Injection, an injectable ...
FiercePharma

ABILIFY® (aripiprazole) Approved for Maintenance Treatment of Bipolar I Disorder as an Adjunct to Either Lithium or

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd., announced today that the U.S. Food and Drug Administration (FDA) has approved ...
PharmiWeb

Abilify Maintena® 960 mg (aripiprazole) approved in the EU as the first once-every-two-months long-acting injectable for the maintenance treatment of schizophrenia

Aripiprazole’s new long-acting injectable (LAI) formulation enables continuous exposure to medication for two months 1. Aripiprazole once-every-two-months LAI is a new formulation containing 960 mg ...
FiercePharma

FDA Approves Deltoid Injection Site for Abilify Maintena® (aripiprazole) for extended-release injectable suspension in the Treatment of Schizophrenia

PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Otsuka America Pharmaceutical, Inc. (OAPI) and Lundbeck today announced that the U.S. Food and Drug Administration (FDA) has expanded the label of ...
The Globe and Mail

FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII® (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI) for the Treatment of Schizophrenia or ...

Otsuka America Pharmaceutical, Inc. (Otsuka) and Lundbeck announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ABILIFY ASIMTUFII ® (aripiprazole) ...
PharmiWeb

Abilify Maintena® 960 mg (aripiprazole) approved in the EU as the first once-every-two-months long-acting injectable for the maintenance treatment of schizophrenia

Aripiprazole’s new long-acting injectable (LAI) formulation enables continuous exposure to medication for two months1 Windsor, United Kingdom/Valby, Denmark, 27 March 2024 – Otsuka Pharmaceutical ...