One-dose “morning after” pill?
This article was originally published in The Tan Sheet
Executive Summary
HRA Pharma currently is conducting its own studies on one-dose levonorgestrel 1.5 mg drug for emergency contraception to be submitted to FDA in early 2004, the Paris-based firm says. HRA Pharma says it is not sure whether the NDA will be submitted for Rx or OTC status, but noted it likely would be difficult to switch OTC from Rx in light of FDA's recent "not approvable" letter to Barr Labs (1"The Tan Sheet" May 10, 2003, p. 5). Barr's current EC regimen includes two pills of levonorgestrel .75 mg taken 12 hours apart...
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