Demulen: hastily approved drug.

  title={Demulen: hastily approved drug.},
  author={D C Goldberg},
  volume={170 3957},
The writer criticizes the acceptance of Demulen as an oral contraceptive on the evidence presented by the Federal Drug Administration (FDA) and the granting of a new drug application (NDA) to G. D. Searle Company. The cited British study included 987 women of whom only 112 were treated with Demulen for 24 or more cycles. A later American study involved only 82 patients treated for 4 cycles. FDA guidelines require a minimum of 200-300 patients for demonstrating the efficacy of an oral… CONTINUE READING