FDA Withdraw The Approval of Niacin and Fenofibric Announced in the Federal Register on April 18, 2016, the U.S. Food and Drug Administration (FDA) disclosed their decision to withdraw earlier approval of niacin and fenofibric acid in combination with statins to treat high cholesterol, according to Medscape. Affected are niacin … [Read more...]
FDA Withdrawn Approval for Some Cholesterol Lowering Drugs
FDA Drug Approvals on the Rise
Data shows that the U.S. Food and Drug Administration (FDA) is approving most drugs that come their way. BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry, was commissioned by Forbes to conduct a new analysis of FDA drug approval rates. That analysis showed that … [Read more...]
FDA Mistakenly Expands Approval For Sleep Drug
Sleep Drug Under Scrutiny. When the Food and Drug Administration (FDA) gave approval for Hetlioz (tasimelteon), a drug to treat non-24 sleep-wake disorder, a rare condition, the agency may have inadvertently omitted language from the label indicating that the drug is intended only for patients who are totally blind. When the FDA … [Read more...]
FDA Approval Does Not Guarantee that Drugs are Safe or Effective
Approval Does Not Guarantee Drugs Safety. When the U.S. Food and Drug Administration (FDA) approves a drug, it does not necessarily mean that the drug is safe or effective for your condition. According to an investigative report by the Milwaukee Journal Sentinel, FDA approval does not guarantee safety or efficacy. The … [Read more...]
Qsymia Approval Raises Safety Worries
Widespread Concerns Over Qsymia Diet Drug Safety. A new prescription obesity and diet drug has been approved for use in the U.S. and like many of its predecessors, there are widespread concerns over its safety. The Food and Drug Administration this week approved Qsymia as a drug treatment for obesity. While early clinical trials … [Read more...]
AstraZeneca Experiences Approval Delays
AstraZeneca Experiences Approval Delays. The release of asthma drug, Symbicort, is being delayed for approval to young children. Reuters said that regulators have asked Symbicort maker, AstraZeneca Plc, for additional information before it can consider allowing expansion of the drug’s use. Symbicort is an inhaled combination … [Read more...]
Drug Coated Stents to Get More Scrutiny from FDA Prior to Approval
Drug Coated Stents Are Being Scrutinized. Drug Coated Stents will soon be subject to more stringent testing requirements. The U.S. Food and Drug Administration (FDA) is planning to release new testing requirements for drug-coated heart stents in the next few weeks, the regulatory agency's device chief, Daniel Schultz, told the Wall … [Read more...]
