Plan B status
This article was originally published in The Tan Sheet
Executive Summary
Barr Labs expects to receive an "approvable" letter from FDA before a Feb. 20 PDUFA deadline for switching its emergency contraceptive pill Plan B (levonorgestrel .75 mg) from prescription to over-the-counter status. During a Feb. 5 earnings call, execs confirmed Barr's R&D group has met recently with the agency regarding the switch application. The Pomona, N.Y.-based firm also maintains the product will be successful for Barr even if it stays an Rx drug. Barr expects to complete the purchase of Plan B developer Women's Capital Corp. within the next two weeks; the firm signed a letter of intent to purchase WCC in October 2003 (1"The Tan Sheet" Oct. 6, 2003, p. 3)...
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