FDA Says Barr Must Delay Its Tamoxifen
Barr Laboratories Inc. must delay introducing its version of AstraZeneca’s tamoxifen cancer drug, the Food and Drug Administration said. The maker of generic drugs said it would sue the agency.
Barr sells tamoxifen through an agreement with AstraZeneca and had hoped to introduce its formula Aug. 20. The FDA ruling would postpone that to February. If the decision stands and Barr runs out of its inventory from AstraZeneca, Barr’s 2003 earnings would be cut by 5% to 8%, or 25 cents to 30 cents, a Barr spokeswoman said.
Barr in 1997 got FDA approval to sell tamoxifen when AstraZeneca’s patents on the drug lapsed. Congress later passed legislation allowing drug companies to claim six additional months of patent protection if they demonstrate their medicines work in children.
Shares of Pomona, N.Y.-based Barr fell $1.82 to $61.83 on the NYSE.
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