(Reuters)—New Hampshire sued OxyContin maker Purdue Pharma LP on Tuesday, joining several state and local governments in accusing the drugmaker of engaging in deceptive marketing practices that have helped fuel a national opioid addiction epidemic. The lawsuit filed in Merrimack County Superior Court claimed that Purdue Pharma significantly downplayed the risk of addiction posed by…
DEA Proposes Cutting Production of Come Opioids
(Reuters)—The U.S. Drug Enforcement Administration (DEA) on Friday proposed a 20% reduction in the manufacture of certain commonly prescribed opioid painkillers, as well as other controlled substances for next year. The proposal comes as U.S. regulators and lawmakers take steps to limit the supply of opioids—a class of drugs that include prescription painkillers and heroin—to…
More Than a Third of U.S. Adults Prescribed Opioids in 2015
(Reuters Health)—The U.S. needs to curb excessive opioid prescribing and improve access to pain management techniques, suggests a new government study. Researchers found that more than one third of U.S. adults were prescribed the medications in 2015 and many also misused the drugs. “A very large proportion and large number of adults use these medications…
Opana ER Pulled from U.S. Market
Endo Pharmaceuticals will work with the FDA to coordinate the organized removal of Opana ER from the U.S. market.
FDA Requests Removal of Opana ER; Plus Abatacept’s New Dosing Option
The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…
FDA Responds to New Drug Application for Baricitinib
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…
FDA Asks Endo to Withdraw Opana ER Opioid
(Reuters)—The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company’s shares down as much as 13%. “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer…
U.S. State, Local Government Lawsuits Over Opioids Face Uphill Battle
BOSTON (Reuters)—A growing number of U.S. states, counties and cities are filing lawsuits accusing drug companies of deceptively marketing opioid painkillers to downplay their addictiveness, but some lawyers say the industry’s highly regulated nature could pose a hurdle to their success. Ohio on Wednesday became the latest, and largest, state or local government to bring…
NSAIDs Increase MI Risk; Plus New Label Warnings for Canagliflozin
NSAIDs Increase Myocardial Infarction Risk According a recent meta-analysis of real-world non-steroidal anti-inflammatory drug (NSAID) use, NSAIDs may increase the risk of acute myocardial infarction (AMI). The analysis used individual patient data meta-analysis of studies from healthcare databases in Canada, Finland and the U.K. to determine the time course for risk of AMI, as well…
FDA Approves Oral Methotrexate; Plus Restrictions for 2 Analgesics in Children
The FDA has approved a new formulation of methotrexate designed as an oral solution for pediatric patients. The agency has also recently introduced age restrictions for codeine and tramadol for children under age 12, citing their risks for slowed or difficult breathing and death…
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