FDA approves Sciele-Novo diabetes drug

PRINCETON, N.J. and ATLANTA The Food and Drug Administration has approved a drug developed by Sciele Pharma and Novo Nordisk to treat Type-2 diabetes, the two companies announced Tuesday.

The drug, PrandiMet, is a fixed-dose combination Prandin and the insulin sensitizer metformin approved to lower blood glucose in adults with Type-2 diabetes for whom metformin alone or meglitinide don’t reduce hyperglycemia.

The two companies announced an agreement last November under which Sciele Pharma would obtain exclusive rights to market Prandin and, upon FDA approval, PrandiMet.

Novo Nordisk reported sales of oral anti-diabetic products, including Prandin, as $134 million for the first quarter of this year.