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.
Are you a nurse practitioner or physician's assistant? Join our Facebook group to get all the latest news dedicated to delivering healthcare services to patients in retail pharmacy clinics.