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CYTARABINE JUNO (Arrotex Pharmaceuticals Pty Ltd)

Product name
CYTARABINE JUNO
Sponsor
Arrotex Pharmaceuticals Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
142 (255 working days)
Active ingredients
Cytarabine
Registration type
New generic medicine
Indication

[TRADE NAME] is indicated primarily for:

  • Induction and maintenance of remission in acute myelocytic leukaemia of both adults and children.

It has also been found to be useful in the treatment of other leukaemias such as:

  • Acute lymphocytic leukaemia
  • Chronic myelocytic leukaemia (blast phase).

[TRADE NAME] may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy.

Children with non-Hodgkin’s lymphoma have benefited from a combination drug program (LSA2L2) that includes cytarabine.

Remissions induced by cytarabine not followed by maintenance treatment have been brief. Maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity.

[TRADE NAME] has been used intrathecally in meningeal leukaemia. Focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine