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CHELSEA ANDA WITHDRAWAL PROCEEDINGS FOR FIVE DRUGS INITIATED BY FDA DUE TO DATA DISCREPANCIES; THERAPEUTIC EQUIVALENCE RATINGS DOWNGRADED TO "BX"

Executive Summary

FDA is beginning proceedings to withdraw ANDAs for five of Chelsea Labs' prescription drug products, the agency said in a Feb. 1 letter to the firm's President Leonard Wydotis. Signed by FDA Office of Compliance Director Daniel Michels, the letter says the agency "is preparing to initiate proceedings to withdraw approval" of six Chelsea ANDAs covering five different generic products. Michels noted that the agency will "change the therapeutic equivalence evaluation for these products" from "AB" (equivalent to the innovator product) to "BX" (inequivalent) while FDA goes through the process of revoking the ANDAs. The Chelsea products include verapamil HCl 80 mg tablets, disopyramide phosphate 100 and 150 mg capsules, perphenazine 8 mg tablets, perphenazine and amitriptyline 4 mg/50 mg tablets, and oxazepam 30 mg capsules. FDA is taking the action "based on its determination that untrue statements, discrepancies, and omissions exist concerning the manufacturing and control of batches used to support approval of the applications," the letter states. An FDA inspection of Chelsea last August-October led the agency to conclude that the company had submitted false information in support of the ANDAs. The conclusion "was based on information contained in the notice of inspectional observations (Form FD 483) issued to Chelsea on Oct. 5, 1989, and on information furnished to FDA by your firm," Michels noted. Observations listed on the Oct. 5 inspection report include the notation that batch sizes and capsule colors recorded for batches of oxazepam differ on separate copies of the batch record and do not conform with the ANDA submission. On verapamil 80 mg, the FD 483 notes that the inspection found two batch records -- a typed one that corresponded to the ANDA submission and an handwritten batch record that indicated that different manufacturing steps were used in the production of the product than reported in the ANDA. An observation listed for perphenazine/amitriptyline states that while the ANDA indicates that tablet coating and polishing was conducted at Chelsea, "actual batch records revealed that the coating and polishing was performed" at a different facility. FDA said it "is currently reviewing the manufacturing and control of batches used to support the approval of additional Chelsea" ANDAs. In a public statement Chelsea said that it "was surprised" by the FDA announcement and that it "hopes to meet with the agency in the very near future to discuss the results of its review" of the documents "and the reason for the unexpected notification." Chelsea noted that it discussed the inspection report with FDA in mid-December "and agreed to expeditiously conduct a review of all relevant records, consult with experts, and report back to the agency regarding the significance of the questions." Chelsea said it "understood the agency to have agreed with this approach and with the company's suggested timetable for completing its review and analysis." The firm said it was puzzled by the timing of the notice because "the review is nearly complete and the timetable has not been exceeded" and the "preliminary results of the review indicate that the questions raised are minor and do not affect the safety or effectiveness of the drugs involved." Chelsea had previously issued an item-by-item response to the FD-483, emphasizing the "historical perspective" as "essential" to the review of the documents. According to Chelsea, "there were virtually no requirements prior to 1985 whereby we would have to submit an executed batch record. When we started submitting the records as hand written documents, the agency requested they be typewritten. When the documents were submitted as typewritten, there were no requirements to designate the specific equipment to be used in manufacturing." The firm added: "In no case did anyone require a specific minimum batch size" until January 1988. The company also noted that the inspection concentrated on Chelsea's older products and that its new standard operating procedure, adopted in early 1988, "addresses the observations listed in the form FD 483."

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