The FDA has granted Supernus Pharmaceuticals tentative approval for its epilepsy drug Trokendi XR. "We will now submit the 'Request for Final Approval' letter to the FDA based on which we expect to receive Final Approval and then launch our product, as anticipated, in the third quarter of 2013," said Supernus CEO Jack Khattar.
The FDA has granted Mylan Pharmaceuticals approval for its fenofibrate tablets in 48 mg and 145 mg strengths to reduce levels of low-density lipoprotein cholesterol, total cholesterol, triglycerides and apolipoprotein B, and boost high-density lipoprotein cholesterol. The drug is a generic version of Abbvie's Tricor.
Ampio Pharmaceuticals obtained FDA approval to initiate a clinical trial of Ampion, a non-steroidal anti-inflammatory biologic drug, in patients with knee osteoarthritis. Ampio is eligible to submit a biologics license application once the trial ends.
The FDA has given Varian Medical Systems 510(k) clearance for a new version of the company's Vitesse system, which allows doctors to plan high-dose-rate brachytherapy for prostate cancer patients in real time. The FDA also has cleared the company's Edge radiosurgery system, which comes with motion management and real-time tumor tracking tools.