Published in FDA Law Weekly, December 16th, 2004
The FDA has requested additional data to support this pill's unique dosing regimen-24 days of active pills followed by 4 days of placebo (inactive) pills. Oral contraceptives typically have a regimen of 21 days of active pills and 7 days of placebo.
In response to this letter, Berlex will submit data to support the clinical benefits of the additional three days of active pills in each cycle. The...
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