Executive Summary

U.S. Appeals Court for the Seventh Circuit upholds an April 1989 Illinois Federal Court preliminary injunction against the sale of eight antibiotics repackaged by Baxter. FDA brought suit against Baxter in 1988, arguing that the repackaging of reconstituted antibiotics into approved solutions and packaging was considered compounding of already approved drugs into new drugs and would require NDA approval ("The Pink Sheet" May 8, 1989, T&G-3). Baxter has asked the circuit court to reconsider its decision. The company says that it no longer repackages the eight antibiotics in question.