Bracco Diagnostics has informed its North American customers that the company has temporarily run out of Kinevac (sincalide for injection).
Kinevac is approved by the U.S. Food and Drug Administration (FDA) for stimulating gallbladder contraction in imaging procedures, among other indications.
Kim Giordano, Bracco's general manager for nuclear medicine, told AuntMinnie.com that the company has been working with its Kinevac manufacturer and supplier to maintain consistent levels of the pharmaceutical. However, the supplier has had a "series of events [and] challenges," independent of Kinevac, that have hampered production.
"Our manufacturer right now is in extended shutdown as part of its maintenance cycle," she said. "I'm sure you can imagine that this just continues to challenge us."
Bracco notified the FDA last week that it was out of stock of Kinevac, adding that new orders would remain on back order and may be partially filled based on availability.
The manufacturer has yet to give Bracco a timetable as to when the pharmaceutical will be available, Giordano said. An update may be available next week.
