Meitheal Pharmaceuticals (Meitheal) is pleased to announce the official launch of mitoXANTRONE Injection, USP (concentrate):
- 71288-178-10 – mitoXANTRONE Injection, USP (concentrate) 20 mg per 10 mL (2 mg per mL), MDV
- 71288-179-13 - mitoXANTRONE Injection, USP (concentrate) 25 mg per 12.5 mL (2 mg per mL), MDV
ABOUT mitoXANTRONE INJECTION, USP (CONCENTRATE)
Mitoxantrone injection, USP (concentrate) is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone injection, USP (concentrate) is not indicated in the treatment of patients with primary progressive multiple sclerosis.
The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability.
Mitoxantrone injection, USP (concentrate) in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer.
Mitoxantrone injection, USP (concentrate) in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.
For full prescribing information, please click on the following link.
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