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Executive Summary

CHASE LABS' NIFEDIPINE CITED BY FDA FOR DISSOLUTION FAILURE in a Dec. 5 warning letter. An Aug. 8 inspection of Chase's Newark, N.J. oral dosage form drug manufacturing facility by FDA revealed "inadequate investigation and documentation of the failure of nifedipine capsules to meet USP XXII dissolution requirements," the letter says. FDA also observed Chase's "failure to validate and document drying times and temperatures for soft gelatin capsules" of the generic calcium channel blocker. FDA's Newark District Office said that no recalls have been initiated in connection with the warning letter. Chase Labs President Richard Remaly indicated that no lots were ever shipped for retail sale in the U.S. that did not pass dissolution testing. Chase met with FDA on Dec. 19 and responded to FDA's Form 483 inspection report on Nov. 14. While the agency called that reply "responsive" in its warning letter, it added that "some questions still remain open." Not enough lots of nifedipine were retested for dissolution, the letter states. Concerning the capsule drying time specifications, "no prospective validation study has been committed to," FDA said. FDA's Newark District Office recommended to the Center for Drug Evaluation and Research that approval of two pending Chase ANDAs be withheld until "all issues pertaining to capsule drying time validation have been addressed and it is certified in writing by [the company] that appropriate corrections have been made," the letter states. The letter also notes that "several" batches of nifedipine 10 mg capsules that failed dissolution specifications were introduced into interstate commerce. The capsules were distributed to charity, which, the letter notes, "has no bearing on their legal status." Chase received the first generic approval for nifedipine 10 mg soft gels in September 1990 after successfully challenging Pfizer's Procardia patent ("The Pink Sheet" Sept. 10, 1990, p. 7).

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