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.