Barr Ortho Tri-Cyclen generic approval “tentative”
Executive Summary
FDA downgrades final approval of Barr's ANDA for generic Ortho Tri-Cyclen to tentative following settlement of patent litigation with Ortho-McNeil. FDA had granted final approval on Dec. 18, 2002 following expiration of 30-month stay. Barr says the change was prompted by company's switch from Paragraph IV certification in ANDA to Paragraph III after Barr acknowledged validity of innovator patent as part of July 31 settlement. Under that agreement, Barr may launch the generic by year-end (1"The Pink Sheet" Aug. 4, 2003, p. 8)...