New FDA Approvals
June 1, 2000 3 minutes read
New FDA Approvals
These drugs have received final approval from the Food and Drug Administration:
- Bisphosphonate Actonel (risedronate sodium) by Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals. Actonel is indicated for treatment and prevention of osteoporosis in postmenopausal women; for the prevention and treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage equivalent to 7.5 mg or greater of prednisone) for chronic diseases; and for treatment of Paget’s disease of the bone (osteitis deformans). Actonel is available as a 5 mg or 30 mg tablet. Recommended doses are 5 mg daily for post-menopausal or glucocorticoid-induced osteoporosis and 30 mg daily for two months for Paget’s disease.
- Anesthetic Chirocaine (levobupivacaine injection) by Purdue Pharma. Chirocaine is now available in the United States for the production of local or regional anesthesia for surgery and obstetrics and for postoperative pain management. It is available preservative-free in 10 mL and 30 mL single-dose vials.
- Recombinant human insulin analog Lantus (insulin glargine [rDNA origin] injection) by Aventis Pharmaceuticals. Lantus has FDA approval for once-daily subcutaneous administration at bedtime in the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. The approval also provides for the OptiPen One Insulin Delivery Device for use with Lantus cartridges. Lantus, at 100 U per mL, is supplied in 5 and 10 mL vials and in 3 mL cartridges (packages of 5).
- Nonsteroidal anti-inflammatory drug (enolic acid group) Mobic (meloxicam) by Boehringer Ingelheim Pharmaceuticals. Mobic is indicated for relief of the signs and symptoms of osteoarthritis, is dosed once daily, and is available in 7.5 mg tablets.
- Photodynamic agent Visudyne (verteporfin for injection) by QLT Phototherapeutics. Visudyne has received FDA approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascular- ization. A course of Visudyne is a two-step process requiring administration of both drug and light. The first step is the intravenous infusion of Visudyne. The second step is the activation of Visudyne with light from a nonthermal diode laser.
- Oxazolidinone antibiotic Zyvox (linezolid) by Pharmacia & Upjohn. Zyvox is indicated for the treatment of adult patients with vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, complicated and uncomplicated skin and skin structure infections, and community-acquired pneumonia caused by strains of designated microorganisms. Zyvox is dosed twice daily and is available in IV form in single-use infusion bags (200 mg/100 mL, 400 mg/200 mL, 600 mg/ 300 mL), 400 and 600 mg tablets, and a 150 mL oral suspension (equivalent to 100 mg/5 mL).
- Antiretroviral agent Viracept (nelfinavir mesylate) by Agouron Pharmaceuticals Inc. Viracept has received approval for a new dosage form, as a film-coated tablet. The new formulation is intended to preserve the tablet integrity and thereby diminish the possibility of premature tablet dissolution and tablet breakage. The dosage strength remains the same.
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