(Supplement)-Drugs receiving FDA approval
These drugs and/or new indications have received final approval from the U.S. Food and Drug Administration:
- New formulation of protease inhibitor Norvir (ritonavir) by Abbott Labs. Twice-daily HIV drug for combination therapy approved as soft-gel capsule as an alternative to its liquid formulation, which was approved last year to replace its original capsule formulation. Also been approved for use in children between ages 2 and 16, drug is recommended with food and at dispensing storage at or below 77 degrees Fahrenheit if taken within 30 days of its original storage temperature of 36 to 46 degrees.
- New indication for Doxil (doxorubicin HCl liposome injection) by Alza Corp. New indication is for treatment of refractory ovarian cancer specific to front-line paclitaxel- and platinum-based chemotherapy, in which disease progresses during treatment or within six months after treatment completion. Approval follows Phase III trials, in which 13.8% of patients reached response rate goal of tumor size reduction of 50% or more. Common side effects: neutropenia, anemia, stomatitis, mild hair loss, rash, fatigue, diarrhea, constipation. Contraindicated for patients sensitive to aminothiol compounds, drug was approved in 1995 for treatment of Kaposi's sarcoma, where disease progression was determined during front-line treatment.
- Xerostomia treatment Ethyol (amifostine) by U.S. Bioscience. Approved for treatment of dry mouth caused by radiation treatment in post-operative head and neck cancer patients experiencing damage to salivary glands. Approval follows Phase III randomized trials of 300 patients resulting in incidences of xerostomia in 51% of patients taking the drug vs. 78% receiving radiation alone. At nine to 12 months after radiation therapy, 34% treated with amifostine continued to experience moderate to severe dry mouth vs. 57% who did not receive the drug, according to trial documents. Common side effects: nausea, hypotension, fever, skin rash, fatigue.
- Urinary tract infection treatment cefadroxil (500 mg) capsules by Barr Laboratories. Approved as generic equivalent to Bristol-Myers Squibb's Duricef.
- Antihypertensive diuretic adjunct triamterene hydrochlorothiazide (37.5 mg/25 mg capsules) by Duramed Pharmaceuticals. Approved as generic equivalent to SmithKline Beecham's Dyazide.
- Antifungal ketoconazole tablets USP (200mg) by Taro Pharmaceuticals. Approved as generic equivalent to Janssen's Nizoral for treatment of topical and systemic fungal infections.
The following drug is still in clinical trials:
- New indication for cancer treatment Taxol (paclitaxel) by Bristol-Myers Squibb. A supplemental New Drug Application (sNDA) has been submitted seeking approval to combine paclitaxel injection with Genentech's Herceptin (trastuzumab) as first-line therapy for metastatic breast cancer treatment in cases of over-expression of HER2 protein, the condition Herceptin is indicated for. The sNDA was submitted after a randomized trial of 469 patients receiving either paclitaxel or a paclitaxel-Herceptin combination. Submitted results showed 38% response rate in those receiving combination vs. a 15% response to paclitaxel alone. Paclitaxel is currently indicated with cisplatin for first-line ovarian cancer; for breast cancer treatment after chemo therapy failure or relapse; for first-line combination treatment for non-small cell lung cancer; and for second-line Kaposi's sarcoma.
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