Bentley/Perrigo get FDA OK for generic simvastatin

Bentley Pharmaceuticals says that its US marketing partner, Perrigo Co, has received approval from the Food and Drug Administration to market generic simvastatin 5mg, 10mg, 20mg, 40mg and 80mg tablets in the USA. 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, Merck & Co's Zocor, whose patent expired on June 23, and 180-day exclusivity period ended on December 19.

The FDA also completed its evaluation and approval of the Bentley manufacturing facility for the production and supply of simvastatin for the US market. In anticipation of this approval, Bentley has already commenced the manufacturing of simvastatin to allow for immediate distribution. However, it notes that there can be no assurance of what the sales levels or pricing will be on formation of the market for generic simvastatin.