Par Pharmaceutical Companies, Inc. has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for fluphenazine decanoate injection, USP 25 mg/mL.
Fluphenazine decanoate injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). Fluphenazine decanoate injection has not been shown effective in the management of behavioral complications in patients with mental retardation.
Par has begun shipping the product, which is individually packaged in 5 mL multiple dose, flip-top vials. According to IMS Health data, annual US sales of fluphenazine decanoate injection are approximately $20 million.
Par Pharmaceutical Companies, Inc. is a privately held, US-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals.