FDA approval to Covidien’s ANDA
The U.S. Food and Drug Administration (FDA) has approved Covidien’s Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. This generic product from the company is pharmaceutically equivalent to Cardiolite®1, a myocardial perfusion imaging agent that is used to detect coronary artery disease. The kit from Covidien will now be available in the market of United States.
- ES Vascular gets CE Marking for OAS system
- OrbusNeich Sapphire catheter receives CE Mark approval
- Thoratec HeartMate II gets FDA nod
- CE Mark approval for Cook Medical’s microcatheter
