The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due to a continual review of these products, FDA is requiring label updates for all prescription NSAIDs. Over-the-counter (OTC) NSAIDs already list the increased risk of MI and…
ZURICH (Reuters)—The U.S. Food and Drug Administration has accepted Novartis unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s blockbuster anti-TNF drug Enbrel, the Swiss drugmaker said on Friday. Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world’s fifth-biggest selling medicine in 2014…
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
Severe and disabling joint pain has been connected to the use of dipeptidyl peptidase-4 inhibitors and combination therapies for diabetes, prompting a new FDA warning…
NEW YORK (Reuters Health)—What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows. The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence…
The FDA has approved new labeling for infused golimumab to include measures of mental and physical health. Plus romosozumab meets primary endpoints in postmenopausal women with osteoporosis during a Phase 3 trial…
MUMBAI (Reuters)—The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action. The FDA’s import alert on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the…
NEW YORK (Reuters)—Pacira Pharmaceuticals Inc. on Tuesday filed a lawsuit seeking a court order allowing it to promote its post-surgery pain drug, Exparel (bupivacaine liposome injectable suspension), for a wide range of surgeries, which the U.S. Food and Drug Administration opposes. The lawsuit, filed in federal court in Manhattan, cites another New York judge’s recent…
Comparing tacrolimus, mycophenolate mofetil and cyclophosphamide, tacrolimus was the most efficacious. Also, biosimilars may soon be easier to differentiate…
(Reuters)—A class of diabetes drugs that include Merck & Co Inc.’s Januvia has been linked with severe joint pain, the U.S. Food and Drug Administration said on Friday. The FDA said it had identified 33 cases of severe joint pain in patients taking a class of drugs known as DPP-4 inhibitors between Oct. 16, 2006,…