FDA committee to review Qnexa
MOUNTAIN VIEW, Calif. A Food and Drug Administration committee will review a drug by Vivus for obesity, the drug maker announced Friday.
The company said the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee was tentatively scheduled to review its application for Qnexa (phentermine and topiramate) on July 15. Vivus submitted its approval application for the drug in late December and expects the FDA to complete its review in October.
“Review by the advisory committee represents a critical milestone for Qnexa and for Vivus,” Vivus CEO Leland Wilson said in a statement. “We believe Qnexa, if approved, could become a treatment option for obese patients.”
FDA approves expanded use of Xifaxan
SILVER SPRING, Md. The Food and Drug Administration has approved a new use for a drug made by Salix Pharmaceuticals, the FDA announced Wednesday.
The agency approved Salix’s Xifaxan (rifaximin) for treating hepatic encephalopathy, a deterioration in brain functioning in patients with liver disease that results from the liver’s no longer being able to clear toxins from the body.
The drug already had approval for treating traveler’s diarrhea.
“The approval of Xifaxan for this new indication provides an additional treatment optin for patients with liver disease,” FDA Division of Gastroenterology Products deputy director Joyce Korvick said in a statement. “Hepatic encephalopathy occurs commonly in patients with liver disease, and there are few effective treatments for this serious condition.”
Teva gets tentative approval for argatroban
JERUSALEM The Food and Drug Administration has given tentative approval to a generic anticoagulant by Teva Pharmaceutical Industries, Teva announced Thursday.
The FDA gave the authorization to the injected drug argatroban, a generic version of a GlaxoSmithKline drug for treating heparin-induced thrombocytopenia that is branded with the same name. The branded version of the drug has annual sales of around $137 million, according to IMS Health.
A tentative approval means that the generic version of the drug meets the conditions for full approval by the FDA, but it can’t be marketed yet because the patent has not expired.