Opinion ID: 788070
Heading Depth: 4
Heading Rank: 2

Heading: ACIC/Brantford Becomes Barr's Only Source

Text: 17 From September 1995 through September 1996, Barr ordered larger shipments of clathrate from ACIC/Brantford, the last of which was shipped in February 1997. On March 26, 1997, the FDA approved Barr's application and authorized it to begin marketing, which it did starting in July 1997. The FDA determined that Barr's warfarin sodium tablets were bioequivalent, and therefore therapeutically equivalent to the name brand drug Coumadin. 18 Barr continued to place orders for large quantities of clathrate from ACIC/Brantford. In a September 1997 document Barr referred to ACIC/Brantford as the only source [of clathrate] available to the generic industry. The district court found that Barr had attempted to secure a back-up producer, but as of March 1998 had not succeeded.