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SUPERPHARM LORAZEPAM AND PROPOXYPHENE/ACETOMINOPHEN PRODUCTION

Executive Summary

SUPERPHARM LORAZEPAM AND PROPOXYPHENE/ACETOMINOPHEN PRODUCTION and distribution are continuing following an internal review of manufacturing procedures by the company. In an Oct. 19 letter to FDA, the firm declared that it intended to continue to manufacture and distribute lorazepam tablets 0.5 mg, 1 mg, 2 mg and propoxyphene napsylate/acetominophen tablets 100 mg/650 mg. The company said that it is currently distributing the products and will continue to do so unless notified otherwise by FDA. Production records associated with the two drugs had been questioned by an FDA investigator in a FD-483 (adverse observations) report issued after an August inspection of Superpharm's Bayshore, N.Y. manufacturing plant. The generic maker told FDA Deputy Director for Generic Compliance Paul Vogel that, after reviewing its records and ANDA submissions, "based . . . on our consideration of all the information available, including both the absence of significant adverse reaction reports and the absence of significant complaints regarding the products' therapeutic effects," the company is "confident" that the ANDAs for both products "are supported by the underlying data" and that both drugs are "safe and effective." The results of the internal review by Superpharm and the continued manufacturing of lorazepam and propoxyphene/acetaminophen temper the allegations made against the firm by FDA witnesses at a congressional hearing in mid-September ("The Pink Sheet" Sept. 18, p. 13). The FDA specifically cited questions about the authenticity of Superpharm's bio samples for its diazepam ANDA. Superpharm suspended production and distribution of all three dosage forms of diazepam that it marketed on Aug. 8. That suspension was voluntarily extended by the company in mid-September pending completion of new bio tests by an outside firm and the submission of those test results to FDA. The scrutiny of Superpharm's records and procedures indicated by the correspondence back and forth between FDA and Superpharm over the last several months is evidence of the effort being exerted by FDA and generic companies in response to the investigation conducted by Rep. Dingell's House Energy & Commerce Oversight Subcommittee. FDA investigators were at the Superpharm facilities for 19 days in May and June, with further followup inspections between August 2 and September 19. As an example of the degree to which FDA is checking the records, one of the disputes between the company and FDA over the propoxyphene records centered on the identification of the tablet coater in the original ANDA. FDA complained that an outside contract coater was not specified in the ANDA or in a supplement submitted in December of 1987. In reply, Superpharm said that although the supplement "did not expressly state" that the coating was performed by an outside firm, that fact was stated indirectly: "it did state that if Superpharm planned to perform the coating in-house at some future time, the company would submit an additional supplement." For lorazepam, also approved in 1987, the principle inspection trouble was a discrepancy between a laboratory notebook containing stability testing data which described lorazepam tablets in the ANDA lot tested for bioequivalency as "embossed with SP 183" where the ANDA had described the tablets from the lot as "smooth with no markings." In reply, Superpharm pointed to other documents submitted with the ANDA, which "correctly describe the tablets . . . as smooth or flat-faced." The remainder of FDA complaints concerned minor discrepancies between lab notebooks and the ANDA, which the agency conceded showed "no apparent pattern that would suggest anything more than random transcription errors." The inspection found no significant bioequivalency problems with either of the products. * In recent months, Superpharm, an affiliate of the Goldline group, has recruited a new president, Otto Nonnenmann, and VP-General Manager, Miriam Clopman, both formerly of Bristol-Myers.

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