ABBOTT's REFORMULATED ISOPROTERENOL NEEDS SUPPLEMENTAL NDA APPROVAL

Executive Summary

ABBOTT's REFORMULATED ISOPROTERENOL NEEDS SUPPLEMENTAL NDA APPROVAL for continued marketing, FDA stated in a May 2 reg letter to the firm requesting that Abbott discontinue manufacturing and marketing the product. "Our investigation revealed that the formulation of [isoproterenol HCl injection 10 ml, 1:5,000] has been changed from that which was submitted and approved under the NDA," the agency said. "The resulting drug product is being marketed and shipped in interstate commerce prior to the approval of supplements to the respective NDA" as reqired by the FD&C Act. Abbott told "The Pink Sheet" that the reformulation consists of "decreasing the titratable acidity of the drug," which "decreases the buffering capacity." The firm noted that it plans to meet with FDAA the week of May 19 to discus the situation. FDA stated that under the FD&C Act "changes in the composition of an approved drug product other than deletion of an ingredient intended to affect the color of the product may not be implemented without prior approval of a supplement to the NDA." FDA also requested Abbott to certify within 30 days that the formulation of all other products are the same as those approved in the firm's NDAs. Bolar received a similar reg letter last year when the firm reformulated 66 Rx drug dosage forms and marketed them without approved supplemental applications ("The Pink Sheet" Aug. 26, p. 3). The reformulation involved changes in the ratios and amounts of inactive excipients. Bolar susequently froze its inventories of the reformulated products and replaced them with the original, approved formulations.