Covidien has received tentative approval from the U.S. Food and Drug Administration (FDA) for a generic version of the Cardiolite technetium sestamibi radiopharmaceutical for myocardial perfusion studies.
The North Billerica, MA, company said that the FDA granted tentative approval to the firm's Abbreviated New Drug Application (ANDA) for preparing technetium sestamibi.
Cardiolite is currently marketed by the company formerly known as Bristol-Myers Squibb Medical Imaging (now owned by Avista Capital Partners), and is scheduled to lose patent protection on July 29. Cardiolite is used in nearly 60% of the 15 million myocardial perfusion procedures conducted annually in the U.S., according to Covidien.
The tentative approval means that the FDA has concluded that Covidien's version of technetium sestamibi is safe and effective for use as labeled, Covidien said. Final approval of the ANDA is subject to the expiration of Cardiolite's patent protection.
Related Reading
Covidien settles Medrad litigation, February 14, 2008
Medrad to buy Possis Medical, February 11, 2008
NRC investigates Covidien production issue, February 8, 2008
Medical sales drive Covidien's Q1 growth, February 7, 2008
Road to RSNA, MRI, Medrad, October 29, 2007
Copyright © 2008 AuntMinnie.com
