The prevalence of metabolic syndrome in women rises with their transition into menopause.
Medscape Medical News
Jump in CV Risk With Menopause Tied to Hormonally Mediated Metabolic Syndrome
SDI Acquires Verispan
Acquisition creates industry leader in patient-level data analytics and consulting services.
PLYMOUTH MEETING, Pa. - July 29, 2008 -SDI, the leader in innovative healthcare analytics announced today that it has acquired Verispan, a top…
MedWatch Safety Alert for mitoxantrone
FDA reminds health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone
FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder
The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.
June 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.
UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain
BRUSSELS, Belguim, July 29, 2008–UCB announced today that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults.
The company will seek…
Antiplatelet Therapies Following Placement of Drug-Eluting Stents: Which Ones and for How Long?
ACC.08: Late and very late stent thrombosis remain a problem following DES placement. What are the latest possible solutions? What is the best type and timing of antiplatelet therapy?
Medscape Cardiology
Mitoxantrone Hydrochloride (marketed as Novantrone and generics)
Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS.
FDA Poorly Equipped To Enforce Off-Label Prescription Drug Marketing Rules, GAO Report Finds
FDA takes an average of seven months to issue warnings to pharmaceutical companies that market medications for off-label uses, and those companies take an average of four months to address the violations, according to a draft report compiled by the Government Accountability Office, the
Schweizerhall: Clopidogrel in Germany – Court Orders Immediate Execution of Approval
BASEL, Switzerland, July 29, 2008–In May 2008 Cimex AG had received approval from the BfArM (Federal Institute for Drugs and Medical Devices, Germany) for clopidogrel (original product: Plavix / Iscover by Sanofi-Aventis / Bristol-Myers…
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