Clear Catheter Systems : US FDA Clearance for the PleuraFlow Active Tube Clearance System

December 13, 2010 — Clear Catheter Systems, Inc, a Bend, Oregon-based medical device company, announced that it has received US Food and Drug Administration clearance for its innovative PleuraFlow™ Active Tube Clearance System. This is a device that can be widely deployed in the post operative management of patients requiring heart and lung surgery. The company has approval to market the device in Europe and Canada, and this regulatory approval clears the way to market the product in the United States for patients recovering from cardiothoracic surgery.
When chest tubes become clogged blood can build up around the heart and lungs which can lead to complications and even death. The PleuraFlow System employs a proprietary active tube clearance system which allows the medical professional to maintain a functioning chest tube in the post operative period... [PDF] Clear Catheter Systems' Press Release -

APP Pharmaceuticals : Approval and Launch of Topotecan for Injection

Nov 30, 2010 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.

Topotecan for Injection is therapeutically equivalent to the reference-listed drug Hycamtin(R), which is currently marketed by the innovator GlaxoSmithKline, plc. According to IMS data, U.S. sales of Hycamtin(R), in 2009 were $157.1 million.

Topotecanfor Injection is indicated for small cell lung cancer sensitive disease after failure of first-line chemotherapy, and is also indicated for use in combination therapy with Cisplatin for stage IV-B, and for recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. APP will market Topotecanfor Injection in 4 mg single dose vials; the product is bar-coded and preservative-free... APP Pharmaceuticals' Press Release -