Amneal Pharmaceuticals received federal approval for its buprenorphine hydrochloride and naloxone hydrochloride dihydrate tablets in two strengths to address opioid dependence. The sublingual therapy is a generic version of Reckitt Benckiser's Suboxone.
BD Rx received federal approval for its metoclopramide injectable drug to address vomiting. The drug is the second product to be approved among the BD Simplist line of pre-filled generic injectables, designed to reduce the number of steps needed before administration.
The FDA has granted Insulet Corporation approval for the new version of its OmniPod Insulin Management System, which features a smaller and lighter insulin pump and a Personal Diabetes Manager glucometer. The new system also calculates insulin on board.
The FDA has given On-X Life Technologies the go-ahead to sell a prosthetic heart valve designed to protect the aortic annulus from flattening and other possible complications. The On-X Aortic Prosthetic Valve comes with an anatomic sewing ring that matches the annulus' anatomy to allow for easier implantation in small patients.
The FDA has granted Biotronik approval for its implantable cardioverter defibrillator that uses advanced sensors and the company's LinoxsmartS DX lead to allow doctors to monitor and detect atrial arrhythmias with just one lead. The device, called Lumax 740 DX System, is targeted for implantation in the U.S. starting late this month or early next month.