Published in Biotech Business Week, March 15th, 2004
Barr and WCC are seeking approval to market the Plan B emergency contraceptive over-the-counter (OTC) without a prescription. The PDUFA extension will permit the FDA to complete its review of the application, including additional data on adolescent use that was submitted by Barr and WCC in support of the application.
Based on its ongoing dialogue with FDA, Barr...
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