New FDA Approvals
September 1, 2000
New FDA Approvals
These drugs have received final approval from the U.S. Food and Drug Administration:
- Anticoagulant Acova (argatroban) Injection by Texas Biotechnology Corp. Argatroban has received FDA approval as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia. Argatroban is a synthetic direct thrombin inhibitor. It is supplied as a concentrated drug (100 mg/mL) that must be diluted 100-fold prior to infusion.
- Lipid-lowering agent Baycol (cerivastatin sodium) by Bayer Pharmaceutical Division. Cerivastatin is indicated for the reduction of elevated LDL-cholesterol in this new, higher-strength tablet (0.8 mg) and for extension of the dosage range to 0.8 mg daily. The FDA also granted approval for the indication of increasing HDL-cholesterol in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb).
- Colazal (balsalazide disodium) by Salix Pharmaceuticals, Inc. Balsalazide is indicated for the treatment of mildly to moderately active ulcerative colitis. It is available in 750 mg capsules. The usual adult dose is three capsules three times daily for a total of 6.75 g per day for eight weeks.
- Low-molecular-weight heparin Innohep (tinzaparin sodium) Injectable by Dupont Pharmaceutical Company for treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium.
- Diabetes agent Glucovance (glyburide and metformin hydrochloride) by Bristol-Meyers Squibb. Glucovance has been approved for two indications: 1) as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be managed satisfactorily with diet and exercise alone, and 2) as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes. Available in tablets of glyburide and metformin 1.25 mg/250 mg, 2.5 mg/500 mg, 5 mg/500 mg strengths.
- Cancer agent Mylotarg (gemtuzumab ozogamicin) for injection by Wyeth-Ayerst. Gemtuzumab is indicated for treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 or older and who are not considered candidates for cytotoxic chemotherapy. The recommended dose is 9 mg/m2, administered as a two-hour intravenous infusion. Patients should receive the following prophylactic medications one hour before gemtuzumab administration: diphenhydramine 50 mg PO and acetaminophen 650-1,000 mg PO; thereafter, two additional doses of acetaminophen 650-1,000 mg po, one every four hours as needed. The recommended treatment dose of gemtuzumab is a total of two doses with 14 days between doses.
These drugs are still in clinical trials:
Clinical study results were recently presented for almotriptan malate (AXERT), a 5HT receptor agonist. Results suggest that almotriptan tablets and sumatriptan (Imitrex) tablets are similarly effective in relieving headache pain at two hours after drug administration. Patients taking almotriptan reported fewer drug-related side effects than patients taking sumatriptan. Pharmacia Corporation is studying almotriptan for the acute treatment of migraine with and without aura in adults.
Aviron has announced initiation of clinical tests with four live attenuated injectable vaccine candidates for the prevention of infection with cytomegalovirus (CMV). CMV is the leading infectious cause of birth defects in the United States. A phase I study is under way to evaluate safety.
Eli Lilly has stopped enrollment in a phase III clinical trial investigating the therapeutic potential of recombinant human activated protein C in the treatment of severe sepsis. An interim analysis found that the placebo-controlled trial results met the criteria for reduced mortality among recombinant human activated protein C-treated sepsis patients. Following a regularly scheduled interim analysis of the study, the Data and Safety Monitoring Board recommended that enrollment cease. Recombinant human activated protein C will be marketed as Zovant if it receives FDA approval.
Entropin Inc. has completed enrollment of its phase IIIA study of Esterom solution as treatment to restore range of motion in patients whose ability to move has been impaired due to acute shoulder injury. The first of two phase III studies, trial enrolled more than 340 patients at 30 U.S. sites.
Article Limit Reached
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content