7:06AM BioDelivery Sciences' releach of Onsolis postponed pending product modification (BDSI) 2.37 : Co announces that the U.S. relaunch of ONSOLIS is being postponed until the product formulation can be modified to address two appearance issues raised by the FDA following a recent inspection of the Aveva manufacturing facility where ONSOLIS is produced. The discussion with FDA centered on the formation of microscopic crystals and a slight fading of the color during the 24-month shelf life of the product. While these changes do not affect the product's underlying integrity or safety, the FDA believes that the fading of the color in particular may potentially confuse patients, necessitating a modification of the product and product specification before additional product can be manufactured and distributed. With regard to this, co states: "While we are disappointed by this unexpected event, the impact is limited as U.S. sales of ONSOLIS were not yet material to BDSI's operations."
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