Bentley Pharmaceuticals Inc., a specialty pharmaceutical company, has announced that its US marketing partner, Perrigo Company, has received approval from the US Food and Drug Administration (FDA) to market generic simvastatin 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tablets in the US.
The FDA has determined that these formulations, which will be manufactured at Bentley's facilities in Spain, are bioequivalent and have the same therapeutic effect as that of the reference drug, Zocor (Merck & Co.), whose patent expired on June 23, 2006 and 180-day exclusivity period expired on December 19, 2006.
The FDA also completed its evaluation and approval of the Bentley manufacturing facility for the production and supply of simvastatin for the U.S. market. In anticipation of this approval, Bentley has already commenced the manufacturing of simvastatin tablets to allow for immediate distribution in the US. There can be no assurance of what the sales levels or pricing will be upon formation of the market for generic simvastatin. "We are pleased with the FDA's approval of our facility to manufacture our first generic drug for distribution in the US market," said John A. Sedor, president of Bentley Pharmaceuticals. "This approval marks an important strategic milestone for Bentley."
Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley's proprietary drug delivery technologies enhance the absorption of pharmaceutical compounds across various membranes. Bentley manufactures and markets a growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiaries -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.