Intended for healthcare professionals


FDA says statin cannot be sold “over the counter”

BMJ 2000; 321 doi: (Published 22 July 2000) Cite this as: BMJ 2000;321:198
  1. Scott Gottlieb
  1. New York

    An advisory committee to the US Food and Drug Administration rejected a request by the US pharmaceutical company Merck for its cholesterol lowering drug lovastatin to be sold “over the counter” (without a doctor's prescription).

    In issuing the rejection, the panel said no evidence showed that it could be used safely and effectively in a consumer setting.

    Lovastatin, introduced in 1987, works by inhibiting hydroxymethyl glutaryl coenzyme A (HMG-CoA) reductase, which stimulates the production of cholesterol in the …

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