Bracco Diagnostics of Princeton, NJ, announced this week that it has received FDA approval to resume manufacture and marketing of Kinevac, the synthetic cholecystokinin drug used to force the gall bladder to contract during nuclear imaging in order to determine ejection fractions. The pharmaceutical is particularly useful for surgeons determining whether to operate on patients with acalculous cholecystitis.
Both Kinevac and a related drug, Choletec, were manufactured for years by Bristol-Myers Squibb and distributed by Bracco. But BMS decided to stop manufacturing the products, forcing Bracco to find another manufacturer. Bracco said it had to place Kinevac on backorder until the process of technology transfer and changing manufacturers took place. The news caused considerable concern among nuclear medicine physicians and technologists when it was announced last year.
Bracco also had to submit a supplemental new drug application (sNDA) to the FDA. The FDA has approved Bracco’s application, and the company said it expects Kinevac to be available around December 23. The vendor’s recent statement made no mention of the availability of Choletec, nor did it name the new Kinevac manufacturer.
By AuntMinnie.com staff writers
December 6, 2002
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Bracco bids to take Esaote private, October 8, 2002
Bracco rations popular gall bladder agents, October 22, 2001
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