FDA approves a Merck NDA for Liptruzet (ezetimibe and atorvastatin) tablets for treating elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia.
Federal Register Notice: FDA seeks comments on a collection of information on the procedure by which applicants obtain designations for combination products.
Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel will meet 6/27 to discuss classifying sorbent hemoperfusion systems and implanted blood access devices for hemodialysis.
Insulet and Eli Lilly enter into an agreement in which Insulet will develop a new version of its OmniPod Insulin Management System that will be designed to deliver Lilly’s Humulin R U-500 insulin.
Newport Medical Instruments recalls its HT70 Ventilator and HT70 Plus Ventilator because the devices go into internal backup battery mode sooner than expected.