Lincolnshire, Ill., February 21, 2019 — Nexus Pharmaceuticals announced today it has received U.S. Food and Drug Administration (FDA) approval for Prochlorperazine Edisylate Injection, USP in 10mg/2mL vial.
“The launch further expands our generic injectable portfolio but more importantly, it shows our commitment to meeting the increased market demand of generic injectables and mitigate the risk of future drug shortages,” said Omair Ahmed, Chief Commercial Officer of Nexus Pharmaceuticals.
Nexus Pharmaceuticals’ Prochlorperazine Edisylate Injection is immediately available in cartons of 10 vials, each containing 10mg of Prochlorperazine Edisylate. It is AP-rated generic.
For wholesaler information, please visit the product page.
About Prochlorperazine Edisylate Injection
Prochlorperazine Edisylate Injection is indicated to control severe nausea and vomiting. It is also indicated for the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
For prescribing information, please see the following link.
About Nexus Pharmaceuticals Inc.
Nexus Pharmaceuticals Inc., a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.
WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Prochlorperazine Edisylate Injection, USP is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Nexus Pharmaceuticals, Inc.