Report: Court OKs agreement between GSK, Apotex over generic Paxil CR
NEW YORK — GlaxoSmithKline can sell an authorized generic of its antidepressant drug to Toronto-based drug maker Apotex, a U.S. judge ruled.
According to a Bloomberg Businessweek report, U.S. District Court judge Joe Pisano ruled the agreement was valid.
In 2008, generic drug maker Mylan entered an agreement with GSK to launch a generic version of Paxil CR. In September 2010, Mylan obtained a temporary restraining order against Apotex when the latter launched its generic version of the drug. One month later, a U.S. District Court denied a motion for a preliminary injunction filed by Mylan to prevent Apotex from making a generic version of the antidepressant drug.
“The language plainly states that GSK may commence marketing and selling of authorized generic Paxil CR after Mylan’s two-year period of exclusivity,” Pisano ruled. “GSK did exactly that. It marketed and sold authorized generic Paxil CR to Apotex.”
Report: GSK recalls blood-pressure drug made at Novartis plant
NEW YORK — GlaxoSmithKline has recalled nearly 400,000 bottles of a hypertension drug that were distributed in the United States, according to published reports.
Reuters Health reported that GSK was recalling 394,230 bottles of its DynaCirc CR after the drug’s manufacturer, Novartis, reported inconsistent packaging practices. The generic drug is manufactured at a Novartis plant in Lincoln, Neb.
No adverse events were reported, GSK was quoted as saying, but the drug maker elected to put forth a recall as a precautionary measure.
Statins could increase blood sugar, cause cognitive problems, FDA says
SILVER SPRING, Md. — Drugs widely used to treat cholesterol may cause increases in blood sugar and other symptoms, the Food and Drug Administration said Tuesday.
The FDA announced that it would update the safety labeling for statin drugs to include the risk of increased blood sugar, or hyperglycemia, memory loss and confusion and risks associated with using certain statins with drugs for treating infections. In addition, the agency is recommending that patients undergo liver enzyme tests before starting statin therapy and as needed thereafter; previously, guidelines called for routine monitoring.
Statins include a wide range of drugs, branded and generic, such as Pfizer’s Lipitor (atorvastatin); Novartis’ Lescol (fluvastatin); Bristol-Myers Squibb’s Pravachol (pravastatin); AstraZeneca’s Crestor (rosuvastatin); and Merck’s Mevacor (lovastatin).
In particular, the agency said, Mevacor should not be used by patients taking drugs for treating HIV, bacterial and fungal infections due to the risk of muscle injuries.