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news.BioDelivery Sciences International has postponed the relaunch of ONSOLIS (fentanyl buccal soluble film) to modify the product formulation as per the appearance issues raised by the FDA.
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The FDA had visited the Aveva manufacturing facility where ONSOLIS is produced and reported the formation of microscopic crystals and fading of the color during the 24-month shelf life of the product.
FDA has announced the necessity to modify the product and its specification before additional product can be manufactured and distributed.
The company believes that the changes are due to an excipient used in the manufacturing process that can be removed to resolve the problem.
BDSI president and chief executive officer Mark Sirgo said the impact of the event is limited as the US sales of ONSOLIS were not yet material to the company’s operations.
"We are confident in our ability to work with our commercial partner, Meda, to make the necessary change to satisfy FDA’s concerns," Sirgo added.