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A website for BioMarin Pharmaceutical's drug Orapred is misleading and skims over the risks associated with taking the drug, the FDA said in a warning letter.
Wholesalers are scrambling to find a strategy to stop the FDA from implementing a drug tracking rule they say will allow a few large companies to monopolize the market, forcing smaller competitors out of business.
The FDA and the Centers for Disease Control and Prevention (CDC) have updated their alert on sanofi pasteur's meningococcal vaccine Menactra after additional reports surfaced of patients suffering from Guillain-Barre Syndrome (GBS) shortly after receiving the drug.
Sen. Chuck Grassley (R-Iowa) is calling on the FDA to provide more details about its decision to remove an agency scientist as a presenter at an advisory committee meeting after what he claims is industry intervention.
The FDA approved Altana Pharma's Omnaris nasal spray for the treatment of nasal symptoms from seasonal and permanent allergies, according to the agency.
The FDA approved AstraZeneca's Seroquel to treat depressive episodes from bipolar disorder, making it the only single medication approved to treat both depressive and manic episodes, the company said.
The attorneys general of California and Alaska have issued subpoenas to AstraZeneca seeking information about its marketing practices for Seroquel (quetiapine fumarate), and the SEC has made an "informal inquiry" to the company regarding payments to foreign doctors and government officials, the company said.
Aventis Pharma has refiled a lawsuit claiming that Baxter's drug Advate infringes on a patent related to factor VIII:c, a protein that helps form blood clots.
A district court granted Mylan Laboratories' motion to dismiss a patent from a lawsuit Pfizer brought against the company over a generic version of the blood pressure drug Norvasc.