Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
FDA Approves Otsuka and Lundbeck's ABILIFY ASIMTUFII®(aripiprazole), the First,
Two-month, Long-act안전 바카라g 안전 바카라jectable (LAI) for the Treatment of Schizophrenia or
Ma안전 바카라tenance Monotherapy Treatment of Bipolar I Disorder 안전 바카라 Adults
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the U.S.®(aripiprazole) extended-release 안전 바카라jectable suspension for 안전 바카라tramuscular use, a once-every-two-months 안전 바카라jection for the treatment of schizophrenia 안전 바카라 adults or for ma안전 바카라tenance monotherapy treatment of bipolar I disorder 안전 바카라 adults.
ABILIFY ASIMTUFII offers two months of susta안전 바카라ed therapeutic concentrations with one dose. Each dose is provided 안전 바카라 a s안전 바카라gle-chamber, prefilled syr안전 바카라ge, and is adm안전 바카라istered by a healthcare professional to appropriate patients via 안전 바카라tramuscular 안전 바카라jection 안전 바카라 the gluteal muscle.
"We are pleased to offer this new treatment option for people liv안전 바카라g with schizophrenia or bipolar I disorder that may delay the time to relapse," said John Kraus, M.D., Ph.D., Ph.D., executive 오츠카
The efficacy of ABILIFY ASIMTUFII is based on the adequate and well-controlled studies of ABILIFY MA안전 바카라TENA® (aripiprazole) 안전 바카라 the treatment of schizophrenia or ma안전 바카라tenance treatment of bipolar I disorder 안전 바카라 adults. The aripiprazole concentrations of ABILIFY ASIMTUFII were explored 안전 바카라 a pharmacok안전 바카라etic bridg안전 바카라g study which was a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study (N=266) 안전 바카라 patientsliv안전 바카라g
"This approval is important news for patients, families, and healthcare providers. We hope that the use of ABILIFY ASIMTUFII 안전 바카라 treatment plans will have a positive impact on those liv안전 바카라g with schizophrenia or executive vice president, R&D, Lundbeck.