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The FDA has approved Purixan (mercaptopurine; NOVA Laboratories Limited) oral suspension for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen.
Since the approval of mercaptopurine in 1953, it has only been available as a 50mg tablet. For pediatric patients with ALL, the tablet formulation has not been optimal due to difficulty with body surface area dosing and adjustments. A suspension formulation allows for more accurate dosing in pediatric patients with a wide range of weights as well as more flexibility in dose adjustments.
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The approval of Purixan was based on one clinical study that assessed the bioequivalence of mercaptopurine from Purinethol tablet (Teva) with that of the mercaptopurine oral suspension in a healthy adult population.
Purixan will be available as a 20mg/mL oral suspension in 100mL bottles.
For more information visit the NovaLabs website.
