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Lercanidipine Approval Status

Lercanidipine is a next generation, long-acting dihydropyridine calcium channel blocker being investigated for the treatment of hypertension.

In August 2002, Forest Laboratories, Inc. received an approvable letter from the FDA seeking additional data related to the proposed dosing regimen. In response to the request, Forest conducted an eight week Phase II pilot study in which approximately 60 patients were dosed once daily with lercanidipine in an experimental modified release formulation. The preliminary study results indicated that this modified release version of lercanidipine was associated with a clinically relevant reduction in blood pressure, but did not meet all the stringent pre-set criteria for dose response across the range of doses studied. Lercanidipine treatment was well tolerated in this study. While lercanidipine is currently available in many countries, it remains commerically undeveloped in the United States.

Development Status and FDA Approval Process for Lercanidipine

Nov  2, 2004Forest Laboratories Updates Lercanidipine Development

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