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news.Par Pharmaceutical Companies 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.
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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 U.S. sales of fluphenazine decanoate injection are approximately $20 million.
Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage. Phenothiazine compounds should not be used in patients receiving large doses of hypnotics. Fluphenazine decanoate injection is contraindicated in comatose or severely depressed states.
The presence of blood dyscrasia or liver damage precludes the use of fluphenazine decanoate. Fluphenazine decanoate injection is not intended for use in children under 12 years of age. Fluphenazine decanoate injection is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.