The FDA has approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery. Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested US donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases. Evithrom is manufactured by Omrix Biopharmaceuticals of Ramat Gan, Israel, and will be distributed by Johnson & Johnson Wound Management, a division of Ethicon, in Somerville, NJ.
Ipsen has announced that the FDA has approved Somatuline Depot (lanreotide) Injection in 60, 90 and 120 mg. versions. Somatuline Depot is indicated for the long-term treatment of the hormonal disorder acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Somatuline Depot will be available in a pre-filled syringe eliminating any need for reconstitution and thus enabling freedom of easy administration to patients.