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These drugs and/or new indications have received final approval from the U.S. Food and Drug Administration:
- Immunosuppressive agent azathioprine tablets, by Mylan Laboratories. As generic equivalent to Glaxo Wellcome’s Imuran. Azathioprine is first of several generic products to receive FDA approval under a collaborative effort between Mylan Laboratories and Genpharm.
- Migraine treatment Maxalt (rizatriptan) by Merck. A 5HT1 agonist indicated for acute treatment of migraine attacks with or without aura. Not intended for prophylactic use. Available in 5 mg and 10 mg tablets.
- Onychomycosis treatment Penlac Nail Lacquer (ciclopirox): Topical Solution 8% by Aventis Pharmaceuticals. A synthetic broad-spectrum antifungal agent indicated for use as a component of a comprehensive management program for the topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Tricho phyton rubrum. The comprehensive management program should include removal of any unattached, infected nails as often as monthly by a health care professional. Solution is applied once daily with an applicator brush to affected nails and adjacent skin.
- Surfactant Curosurf (poractant alfa) Intratrach eal Suspension by Dey Laboratories. A non pyrogenic pulmonary surfactant indicated for the treatment (rescue) of Respiratory Distress Syn drome in premature infants. The drug is supplied in ready-to-use rubber-stoppered glass vials containing 1.5 mL (120 mg phospholipids) or 3 mL (240 mg phospholipids) of suspension.
- Carnitor (levocarnitine) Injection by Sigma-Tau Pharmaceuticals. Carnitor has been approved for the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. It is available as 200 mg/mL in 2.5 mL and 5 mL ampoules.
- Breast cancer agent Aromasin7 (exemestane) tablets by Pharmacia & Upjohn. The new drug application was approved for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. The drug is available in a 25 mg dose.
- Oral cephalosporin Omnicef (cefdinir) capsules by Parke-Davis. The FDA has approved the capsules for a five-day dosing regimen (300 mg bid) for the treatment of acute exacerbations of chronic bronchitis.
- Sedative Precedex (dexmedetomidine HCl) by Abbott Laboratories. Precedex is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours.
- Combination antiplatelet agent Aggrenox (aspirin/extended-release dipyridamole) capsules by Boehringer Ingelheim Pharmaceu ticals. Aggrenox received FDA approval to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. The drug is available as a capsule containing 25 mg aspirin and 200 mg dipyridamole in an extended-release form.