New FDA Approvals
February 1, 2001
New FDA Approvals
These drugs have received final approval from the Food and Drug Administration:
Oral contraceptive desogestrel/ethinyl estradiol (Cyclessa) by Organona Inc.
Fomepizole (Antizol) injection by Orphan Medical Inc. Fomepizole is approved for suspected or confirmed methanol poisoning, either used alone or in combination with hemodialysis.
Antiviral agent oseltamivir (Tamiflu) oral suspension by Hoffman-La Roche. Oseltamivir is now available for oral use for the treatment of uncomplicated acute illness due to influenza in patients older than 1 year of age who have been symptomatic for no longer than two days. The agent significantly reduced the total composite time to freedom from illness (resolution of fever, alleviation of coyza and cough, and parental opinion of return to normal health and activity) by 1.5 days compared to placebo. Adults who have difficulty swallowing the capsule may use the oral suspension.
Diabetes agent nateglinide (Starlix) by Novartis. Nateglinide is approved for use as monotherapy, as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes. In addition, this approval provides for the use of nateglinide concomitantly with metformin to improve glycemic control. Nateglinide is available in 60 mg and 120 mg tablets.
Anticoagulant bivalirudin (Angiomax) injection by the Medicines Co. Bivalirudin has received approval for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.
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