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.
Anemia treatment can benefit patients with heart, kidney, and cancer woes
July 15th 2002On June 6, the American Medical Association held a media briefing on anemia, funded by an unrestricted educational grant from Amgen, Inc. Topics included anemia and heart failure and new strategies for treating anemia associated with cancer treatment.
FDA approves restricted marketing of alosetron
July 1st 2002On June 7, the FDA announced that it had approved a supplemental New Drug Application for alosetron. The drug is approved for the treatment of women with severe diarrhea-predominant irritable bowel syndrome, who have failed to respond to conventional IBS therapy. Alosetron will become available again, possibly within the next 6 months, through a restricted marketing program.
New antifungal approved for aspergillosis
June 17th 2002Pfizer recently announced that it has received marketing approval from the US Food and Drug Administration for voriconazole (Vfend tablets) and voriconazole for injection (Vfend I.V.) for use in the treatment of invasive aspergillosis and the treatment of serious fungal infections caused by Scedosporium apiospermum and Fusarium spp in patients intolerant of, or refractory to, other therapy.
New injection approved to treat infertility
June 3rd 2002The US Food and Drug Administration (FDA) recently approved urofollitropin for injection, purified (Bravelle, Ferring Pharmaceuticals) for the treatment of infertility. Urofollitropin is a highly purified follicle-stimulating hormone derived from the urine of postmenopausal women