Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
The second annual ACR Division Directors’ Conference took place in Chicago on March 10–11. The conference opened with a presentation on the use of the ACR’s Rheumatology Informatics System for Effectiveness (RISE) Registry in academic medical centers by Salahuddin “Dino” Kazi, MD, from UT Southwestern Medical Center, and Jinoos Yazdany, MD, MPH, from the University of California…
WASHINGTON, D.C.—Rheumatologists do not have up-to-date diagnostic and classification criteria for vasculitis, a group of diseases that involves inflammation of the blood vessels, said experts speaking at the 2016 ACR/ARHP Annual Meeting session, Classification Criteria for ANCA-Associated Vasculitis. The most recent classification criteria were published by the ACR in 1990, and since then, new disease…
Although the FDA has not yet awarded the title of interchangeable to any biosimilar, legislation that governs their substitution will continue to be a dominant state issue in 2017. Since 2013, 24 states and Puerto Rico have passed legislation regarding interchangeable biologics. As many as 15 states will have biosimilar-related legislation introduced by coalitions in…
Cross Reactions A recent study published online in March in the Annals of the Rheumatic Diseases investigated if the infliximab biosimilar (CT-P13, infliximab-dyyb), which is marketed in Europe as Inflectra and Remsima, can be safely and effectively substituted for infliximab (Remicade).1 Infliximab and its biosimilar are manufactured via the same process. Researchers set out to…
CHICAGO—Researchers have come to know a great deal about IgG4-related disease in a short amount of time, leading to effective treatments with the prospect for more, an expert said at the 2016 State-of-the-Art Clinical Symposium. “One of the most exciting things for me is how quickly we’ve been able to move in understanding this disease,”…
SAN FRANCISCO—In a presentation on advances in the treatment of systemic lupus erythematosus (SLE) at the California Rheumatology Alliance 2016 Medical & Scientific Meeting in May, Maria Dall’Era, MD, director of the Lupus Clinic and Rheumatology Clinical Research Center at the University of California, San Francisco, discussed the range of treatments that have been identified…