Published on July 4, 2007 at 10:55 PM
Barr Pharmaceuticals has announced that Gedeon Richter, Plc. has received final U.S. Food & Drug Administration (FDA) approval for its application to manufacture and market a generic version of Novartis Pharmaceutical Corporation's LAMISIL (terbinafine hydrochloride) Tablets, 250 mg. The approval follows the expiration of pediatric exclusivity for LAMISIL.
Under the terms of an agreement with Gedeon Richter, Gedeon Richter will manufacture the product and Barr will market the product in the United States and pay Gedeon Richter a royalty. Barr plans to launch the product immediately.
LAMISIL had annual sales of approximately $685 million for the twelve months ended April 2007, based on IMS sales data.
Terbinafine hydrochloride tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes.
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