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Ultra low-cost artificial leg developed
JERUSALEM, July 3 (UPI) -- Teva said Tuesday the U.S. Food and Drug Administration approved its generic formulation of Novartis' anti-fungal agent, Lamisil tablets.
Teva said it will immediately begin shipping its product.
The FDA's approval covers the company's abbreviated new drug application for 250 mg tablets of terbinafine, the active ingredient in Lamisil. In addition to Teva, the FDA approved generic versions of Lamisil tablets from several other manufacturers, including Apotex, Dr. Reddy's Laboratories and Mylan.
Annual U.S. sales for Lamisil were approximately $685 million for the 12 months ended March 31. The drug is indicated for treating onychomycosis, a fungal infection of fingernails or toenails.
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