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Dec 22, 2006

Bentley Pharmaceuticals’ Generic Simvastatin Approved for U.S. Market

  • Bentley Pharmaceuticals’  U.S. marketing partner, Perrigo, received approval from the U.S. FDA to market generic simvastatin 5-mg, 10-mg, 20-mg, 40-mg and 80-mg tablets in the U.S. 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’s Zocor®, whose patent expired in June 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 U.S. There can be no assurance of what the sales levels or pricing will be upon formation of the market for generic simvastatin.



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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

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