Upsher-Smith has received approval on from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.
Janssen Biotech announced that the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy.
Salix Pharmaceuticals announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.
Johnson & Johnson and Pharmacyclics have added a New York-based specialty pharmacy company focused on cancer to their limited-distribution network for a drug recently approved for a rare form of blood cancer.
Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.