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A third party tampered with the labels on two GlaxoSmithKline (GSK) HIV infection medications, placing incorrect and counterfeit labels on the products, the company and the FDA announced.
GlaxoSmithKline (GSK) could see a boost to sales for its antiviral treatment Relenza following reports of a Japanese Health Ministry recommendation against Tamiflu use in teenagers because of reports of abnormal behavior.
The FDA has recommended that manufactures of sleep agents initiate clinical studies to determine the incidences of sleep-driving and other complex sleep behaviors that have been observed in postmarketing reports, the agency said March 14.
An analysis of 84 studies by HHS’ Agency for Healthcare Research and Quality (AHRQ) found no strong evidence that atypical antipsychotics are effective for many of the off-label uses for which they are commonly prescribed.
Law enforcement currently takes too prominent of a role in setting off-label enforcement policy, necessitating regulations to establish more consistent policy, an industry attorney said.
The federal government’s $435 million settlement with a subsidiary of Schering-Plough is part of a multiyear crackdown on off-label drug promotion that is likely to dramatically reduce practice, various sources say.
Johnson & Johnson (J&J) has disclosed that three of its subsidiaries have received three separate subpoenas from the Boston, San Francisco and Philadelphia U.S. attorney’s offices relating to marketing practices for Risperdal, Topamax and Natrecor.
The FDA issued letters to manufacturers of all attention-deficit/hyperactivity disorder (ADHD) products asking them to implement new medication guides, saying it is concerned about cardiovascular risks and adverse psychiatric symptoms.