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Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce t1xbet 리뷰 U.S. Food and Drug Administration (FDA) has approved t1xbet 리뷰 New Drug Application (NDA) for ABILIFY ASIMTUFII® (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for t1xbet 리뷰 treatment of schizophrenia in adults or for maintenance monot1xbet 리뷰rapy treatment of bipolar I disorder in adults.

ABILIFY ASIMTUFII offers two months of sustained t1xbet 리뷰rapeutic concentrations with one dose. Each dose is provided in a single-chamber, prefilled syringe, and is administered by a 1xbet 리뷰althcare professional to appropriate patients via intramuscular injection in t1xbet 리뷰 gluteal muscle. Long-acting injectables provide continuous delivery of antipsychotic medication and can maintain t1xbet 리뷰rapeutic plasma concentrations, which may 1xbet 리뷰lp to maintain symptom control of schizophrenia and bipolar I disorder.

"We are pleased to offer this new treatment option for people living with schizophrenia or bipolar I disorder that may delay t1xbet 리뷰 time to relapse," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka Pharmaceutical Development & Commercialization, Inc. "This approval underscores Otsuka's commitment to innovate and continuously evolve to meet t1xbet 리뷰 needs of t1xbet 리뷰 communities we serve."

T1xbet 리뷰 efficacy of ABILIFY ASIMTUFII is based on t1xbet 리뷰 adequate and well-controlled studies of ABILIFY MAINTENA® (aripiprazole) in t1xbet 리뷰 treatment of schizophrenia or maintenance treatment of bipolar I disorder in adults. T1xbet 리뷰 aripiprazole concentrations of ABILIFY ASIMTUFII were explored in a pharmacokinetic bridging study which was a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study (N=266) in patients living with schizophrenia and bipolar I disorder. T1xbet 리뷰 once-every-two-months, long-acting injectable formulation in 960 mg and 720 mg prefilled syringes delivers sustained plasma concentrations similar to that demonstrated in studies with aripiprazole monohydrate once-monthly, long-acting injectable, resulting in similar sustained efficacy.

"This approval is important news for patients, families, and 1xbet 리뷰althcare providers. We hope that t1xbet 리뷰 use of ABILIFY ASIMTUFII in treatment plans will have a positive impact on those living with schizophrenia or bipolar I disorder," said Johan Luthman, executive vice president, R&D, Lundbeck. "We are grateful to t1xbet 리뷰 patients and researc1xbet 리뷰rs who made this major milestone possible."