FDA gives tentative approval to Lunesta generic
BALTIMORE Lupin has received tentative approval for a generic version of a popular insomnia treatment.
Lupin has received tentatively approval for eszopiclone tablets in 1-mg, 2-mg and 3-mg strengths. The tablets are the generic equivalent of Sepracor’s Lunesta.
Commenting on the approval, Vinita Gupta, president and CEO of Lupin Pharmaceuticals, said, “We are pleased to receive this tentative approval and look forward to bringing Eszopiclone tablets to the US market as an affordable generic alternative post patent expiry [in 2012].”
Lunesta garnered annual sales of approximately $761 million for the twelve months ended December 2009, based on IMS Health sales data.
Retail Clinician special report focuses on patient-centered care
NEW YORK Drug Store News’ sister publication, Retail Clinician, has issued a special report on an exclusive study conducted by Take Care Health Systems in conjunction with Gallup Consulting that measured patient engagement levels among Take Care Clinic visitors, with an eye toward elevating the patient experience.
The report, which is anchored by the original white paper — written by Sharon Glave Frazee, Ph.D., VP corporate healthcare analytics and research team for Walgreens, along with John H. Fleming, Ph.D., principal, chief scientist customer engagement and humansigma®, Gallup, and Margaret Ozan Rafferty, R.N., M.H.A., M.B.A., healthcare global practice leader for Gallup — and also includes an interview with Take Care CEO Peter Miller discussing the significance of the findings and what it means both for Walgreens and Take Care, and the impact Take Care’s unusually high levels of patient engagement is having on clinic traffic.
A copy of the report can be downloaded here.
High doses of cholesterol drug may raise muscle injury risk, FDA warns
SILVER SPRING, Md. Patients taking a common drug for treating high cholesterol may be at increased risk of muscle injury, the Food and Drug Administration warned Friday.
The FDA warned patients and healthcare professionals of the risk of muscle injury, also known as myopathy, in patients taking simvastatin in the 80-mg strength. Though muscle injury is a side effect common among all statins, the agency said patients taking higher doses of simvastatin run a higher risk. Of particular concern is the risk of rhabdomyolysis, a severe form of myopathy that can lead to kidney damage, kidney failure and sometimes death.
Merck originally marketed simvastatin under the brand name Zocor, and it is now available as a generic from several suppliers. It’s also an active ingredient in several other cholesterol-lowering drugs, including the Merck’s Vytorin (ezetimibe and simvastatin) and Simcor (niacin and simvastatin), marketed by Abbott and Solvay Pharmaceuticals. All formulations of Simcor contain only 20 mg of simvastatin, though Vytorin is available with 80 mg, according to an FDA database.
“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available,” FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said in a statement. “It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”