DIPYRIDAMOLE ANDAs/ANDA SUPPLEMENTS WILL REQUIRE IN VIVO STUDIES
Executive Summary
DIPYRIDAMOLE ANDAs/ANDA SUPPLEMENTS WILL REQUIRE IN VIVO STUDIES to show bioequivalence to the innovator product (Boehringer Ingelheim's Persantine) for labeling "as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement," FDA told Boehringer Ingelheim in a March 7 letter. "FDA will require that each ANDA and supplemental ANDA for a dipyridamole product bearing the new indication contain a human in vivo bioequivalence study demonstrating that the proposed product has the same rate and extent of absorption as Persantine tablets," FDA said. * The agency's letter responds to a Dec. 15 petition from the firm requesting that FDA require generic companies to conduct in vivo studies to gain approval for the indication. Boehringer's exclusivity for the cardiac valve replacement indication ran out on Dec. 22. Although FDA withdrew dipyridamole's angina indication in early 1987, approximately 20 generic companies have continued to market the product on a "conditional" basis while FDA reviews their requests for hearings. Some generic companies, including Duramed, reportedly have already submitted ANDA supplements to gain approval for the cardiac valve replacement indication.
DIPYRIDAMOLE ANDAs/ANDA SUPPLEMENTS WILL REQUIRE IN VIVO STUDIES to
show bioequivalence to the innovator product (Boehringer
Ingelheim's Persantine) for labeling "as an adjunct to coumarin
anticoagulants in the prevention of postoperative thromboembolic
complications of cardiac valve replacement," FDA told Boehringer
Ingelheim in a March 7 letter. "FDA will require that each ANDA and
supplemental ANDA for a dipyridamole product bearing the new
indication contain a human in vivo bioequivalence study
demonstrating that the proposed product has the same rate and
extent of absorption as Persantine tablets," FDA said. |