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news.Breckenridge Pharmaceutical has received FDA's final approval for its abbreviated new drug application (ANDA) for Terbinafine HCl tablets, 250mg.
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Breckenridge Pharma is a pharmaceutical marketing, research and development company founded in 1983 that markets a range of generic prescription products in many therapeutic categories including several ValuBrand products.
Breckenridge Pharma claimed that Terbinafine HCl tablets are AB rated to Lamisil, a brand product marketed by Novartis. Breckenridge plans to launch the product this summer.
Lamisil fights fungal infections. In tablet form, it’s used for fungus of the toenail or fingernail.The cream and the solution are used for other fungal infections such as athlete’s foot, jock itch, and ringworm.
Additionally, the solution is also used to treat tinea versicolor, a fungal infection that produces brown, tan, or white spots on the trunk of the body.
Earlier, Mylan Laboratories had also received FDA approval on July 2, 2007 for Terbinafine Hydrochloride (HCl) tablets, 250 mg ANDA.