Perrigo wins tentative FDA approval for generic Prandin

ALLEGAN, Mich. – The Food and Drug Administration has given tentative approval to a generic diabetes drug.

Perrigo Co. announced the tentative approval for repaglinide tablets, a generic version of Novo Nordisk's Prandin, used to treat Type 2 diabetes.

Tentative approval means that the drug meets the basic conditions for FDA approval, but the agency must wait to grant final approval until patent-protection or market exclusivity periods have ended; in the case of Prandin, India-based Sun Pharmaceutical Industries won approval for a generic version of the drug and will have 180 days in which to compete exclusively with Novo Nordisk's product.

Prandin has annual sales of about $250 million, according to Symphony Health Solutions.

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