Otsuka and Lundbeck announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the ...
Data from Phase 3 Trial demonstrated improvement in time to relapse, the primary efficacy endpoint, for patients receiving once-monthly aripiprazole IM depot formulation compared to placebo Results ...
* Submission based on data from pivotal trials evaluating efficacy, safety and tolerability in patients suffering from schizophrenia * Lundbeck has co-development and co-commercialisation rights to ...
Otsuka and H. Lundbeck announced that the FDA has accepted for review its New Drug Application (NDA) for once-monthly aripiprazole depot formulation for the maintenance treatment of schizophrenia in ...
"Aripiprazole, a dopamine, D 2 partial agonist with its unique pharmacological profile, has been prescribed around the world while recognized as an important long-term treatment option for patients ...
New Depot Formulations Will Command Premium Pricing and Their Sales Will Offset Those Lost to the Generic Erosion of Janssen’s Risperdal Consta, According to Findings from Decision Resources ...
FDA establishes PDUFA action date of 28 February 2013. Lundbeck has co-development and co-commercialisation rights to aripiprazole depot formulation in North and Latin America as well as Europe, ...
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 ...
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