Issue link: https://www.e-digitaleditions.com/i/701238
the first and currently only fixed-dose combination of a beta blocker and an angiotensin II receptor blocker avail- able in the USA. FDA approves first buprenorphine implant SILVER SPRING, MD—The FDA approved Titan Pharmaceuticals' Probuphine, the first buprenorphine implant for the treatment of opioid dependence. Prior to its approval, buprenorphine was only approved as a tablet, capsule, or oral film. Probuphine comprises four 1-inch-long rods implanted under the patient's skin to provide a constant, low-level dose of the drug product for 6 months as part of a treatment program for people who are already stable on low to moderate doses of buprenorphine. CDER awards Biopharma $20 million for generic drug product study COLUMBIA, MO—BioPharma Services USA, a contract research organization, won a 5-year, $20 mil- lion contract with the Center for Drug Evaluation and Research (CDER) to conduct in vivo studies of generic drug products in human sub- jects from 2016 through 2021. The study's goal is to improve generic review practices within CDER. Briefly noted… Novartis, Basel, Switzerland, split its pharmaceutical division into two business units, Novartis Pharma- ceutical and Novartis Oncology, to form the innovative medicines divi- sion. The goal of the restructuring is to focus its pharmaceutical section and integrate the oncology assets it acquired from GSK. NSF International established a center of excellence for pharmaceuti- cal development at its Bristol, CT, lab- oratory. It will provide technical sup- port, analytical testing, education, and training to through its laboratories in Germany, China, Peru, and Brazil. The Canadian province of Alberta has begun regulating the sale of tablet presses and capsule fillers to prevent the illicit manufacture of fentanyl and other drug products. 8 July 2016 Tablets & Capsules between May 31 and June 7, resulting in the seizure of drug products in San Francisco, New York, and Chicago. Fifty-three website operators were issued warning letters for selling unap- proved, misbranded drug products. Allergan receives FDA approval for Byvalson DUBLIN, IRELAND—The FDA approved Allergan's Byvalson (nebi- volol and valsartan) for treatment of hypertension. The once-daily tablet is