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Contraception
FDA extends Plan B emergency contraceptive PDUFA date
March 15th, 2004
Barr Pharmaceuticals, Inc., (BRL) and Women's Capital Corporation (WCC) said that the U.S. Food and Drug Administration (FDA) has extended the original 10-month Prescription Drug User Fee Act (PDUFA) deadline for completion of its review of the Plan B Supplemental New Drug Application (sNDA). 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...
Source: OBGYN & Reproduction Week (2004-03-15)
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