Avista Capital gains FDA exclusivity extension for Cardiolite

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Avista Capital Partners reported that the FDA has granted pediatric exclusivity for studies conducted on Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), which is part of its recently acquired medical imaging (MI) business from Bristol-Myers Squibb.

The grant extends the marketing exclusivity of Cardiolite for an additional six months beyond patent expiration on Jan. 29, the company said.

“We believe that this is the first pediatric exclusivity grant for an imaging agent and is the result of extensive clinical trials, involving more than 600 patients in nine countries over three years,” according D. Scott Edwards, vice president of research and development at MI.

Avista Capital Partners acquired the medical imaging business on Jan. 8 of this year.