New antihypertensive has unique mechanism of action
October 21st 2002Patients whose hypertension remains inadequately controlled despite the availability of several classes of antihypertensive drugs will soon have a therapeutic option with a unique mechanism of action. Eplerenone is the first agent that selectively binds to the mineralocorticoid receptor and blocks the binding of aldosterone.
First nucleotide analog approved for hepatitis B
October 21st 2002On September 20, the FDA approved adefovir dipivoxil (Hepsera, Gilead Sciences) for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active liver disease. Adefovir dipivoxil is the first nucleotide analog to be approved for the treatment of chronic infection with hepatitis B. Adefovir dipivoxil is an acyclic analog of deoxyadenosine monophosphate.
New colorectal cancer drug approved in record time
September 2nd 2002The recent approval of oxaliplatin (Eloxatin, Sanofi-Synthelabo) by the FDA provides a treatment option for patients who previously did not have any alternatives except symptom-directed care. The Agency approved oxaliplatin, for use in combination with 5-fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first-line therapy with the combination of bolus 5-FU/LV and irinotecan (Camptosar, Pharmacia & Upjohn).
First drug to treat irritable bowel syndrome approved
August 19th 2002The FDA recently approved tegaserod (Zelnorm, Novartis), the first drug for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. It is also the first agent in a new class of drugs. Tegaserod is a 5-HT4 receptor partial agonist.
New formulation of lovastatin reduces cholesterol levels
August 5th 2002On June 27, Andrx Corporation announced that the FDA had granted final marketing approval for its extended-release lovastatin (Altocor) to slow the progression of atherosclerosis in those with coronary heart disease as part of a therapeutic strategy to lower LDL-cholesterol (LDL-C) and total cholesterol (total-C). Extended-release lovastatin is also indicated as an adjunct to diet for the reduction of total-C, LDL-C, Apolipoprotein B, and triglycerides, and to increase HDL-cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.