Nova Laboratories announces FDA filing of New Drug Application

Nova Laboratories announces FDA filing of New Drug Application for the treatment of childhood acute lymphoblastic leukemia (ALL)

UK pharmaceutical manufacturer Nova Laboratories announced that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for childhood acute lymphoblastic leukemia (ALL) medicine that is marketed in the EU as Xaluprine™.

The product – a liquid formulation of mercaptopurine – has been granted orphan drug designation by the FDA, a status given to a product intended for the treatment of a rare disease or condition.  Nova is seeking FDA approval for the treatment of children with ALL. 

Nova has partnered with Rare Disease Therapeutics, Inc. who will act as distributor for the product in North America. Nova says it hopes Xaluprine™ will be available in the US market by the second quarter of 2014.

Dr Hussain Mulla, head of clinical development for Nova, said the product had been well received by European hematologists, pharmacists and oncology nurses:

“Healthcare professionals have acknowledged that the product allows considerably more accurate doses to be administered than when using tablets and provides greater palatability than existing tablet treatments.

“The product also eliminates safety concerns around clinicians or caregivers being exposed to cytotoxic dust when splitting tablets.

“After a successful launch in Europe, we’re now looking to develop other markets, including the US, to help make life easier for children living with this disease as well as their caregivers.”


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