(Reuters)—The U.S. Food and Drug Administration staff reviewers have raised concerns about kidney- and heart-related side effects noted in trials on AstraZeneca Plc’s gout treatment, especially at higher doses. FDA reviewers, in a preliminary review published on Wednesday, expressed concerns over higher death rates related to the side effects in patients who took the drug,…
FDA Declines to Expand Approval of Pfizer Arthritis Drug Xeljanz
(Reuters)—U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz (tofacitinib) to treat moderate to severe cases of plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must be addressed in order…
FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning
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…
Novartis Biosimilar Takes Aim at Amgen’s Enbrel
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 for RA Is Safe Long Term, Plus Oxycodone Update
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
FDA Issues Warning for Joint Pain from Diabetes Drugs
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…
FDA’s ‘Breakthrough Drug’ Terminology Confuses the Public
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…
New Labeling for Infused Golimumab; Phase 3 Trial for Romosozumab Promising
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…
U.S. Bans Another Indian Drug Plant over Production Quality
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…
Pacira Sues FDA over Pain Drug Marketing Restrictions
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…
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