March 3, 2008 – Covidien said that it has tentative FDA clearance for its Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, a generic of Cardiolite1, which is a myocardial perfusion imaging agent used for detecting coronary artery disease.
The branded product is utilized in nearly 60 percent of the 15 million myocardial perfusion imaging studies performed in the U.S. annually.
Tentative FDA approval indicates that the FDA has concluded that Covidien’s generic product is safe and effective for use as recommended in the submitted labeling. Final approval of the ANDA, which was filed by the Company’s Mallinckrodt Inc. subsidiary, is subject to the expiration of the marketing exclusivity period for the branded product on July 29, 2008.
For more information: www.covidien.com