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GLAXO SEEKING DELAY OF LILLY CEFTAZIDIME ANDA APPROVAL

Executive Summary

GLAXO SEEKING DELAY OF LILLY CEFTAZIDIME ANDA APPROVAL through a recent petition to FDA, asserting that its new cephalosporin antibiotic is entitled to five years exclusivity under the Waxman/Hatch law. In the petition, Glaxo outside counsel Peter Safir (D.C. law firm of Kleinfeld, Kaplan & Becker) requested "a stay of the processing for approval (or the effective date of approval) ]of ANDAs for[ the drug ceftazidime until . . . July 19, 1990, five years after the first approval of ceftazidime pursuant to the new drug application submitted by Glaxo." Glaxo said in its petition that it believes Lilly has already filed an ANDA for ceftazadime with the FDA. Although the patent for ceftazadime has not yet run out, both Lilly and SmithKline have claimed rights to the antibiotic. Approval of the Lilly application before July 19, 1990 would "illegally" deprive Glaxo of its "five-year period of exclusive marketing under the Drug Price Competition and Patent Term Restoration Act of 1984," Glaxo maintains. Glaxo is arguing that because antibiotics are exempt from certification, "and therefore regulated as new drugs under terms of the FDC Act," they are implicitly covered by the exclusivity portion (Title I) of the Waxman/Hatch Act. While the "legislative history does not explicitly state Congressional intent to include antibiotics in the coverage of the exclusivity provisions," the petition asserts, "there is no indication anywhere" that antibiotics regulated as new drugs "were intended to be excluded." Had Congress "intended to exclude antibiotics exempt from certification from the provisions of Title I, it should have expressly done so," Safir argued. "Therefore, since the explicit language of the exclusivity provisions of the Act clearly includes antibiotics regulated as new drugs, the Act should be taken at face value." In addition, Glaxo maintains that unlike most antibiotics where safety and efficacy data for the drug are made public, FDA decided that there were "extraordinary circumstances" with respect to caftazidime. "Under the agency's published policy, therefore, applicants for approval of generic versions of ceftazidime may not rely on this data and FDA may approve such products only if the generic applicant has submitted sufficient independent safety and efficacy data of its own," the Glaxo petition asserts. As part of its NDA for ceftazidime, Glaxo said it had to submit specifications regarding levels of high molecular weight polymer (HMWP) in the drug substance and pyridine in the finished product before the antibiotic could be approved. Generic products should have to meet these specifications, Glaxo said. The firm added that only its studies established a relationship between pyridine and HWMP levels in the drug product, and that "a similar relationship must be shown for any generic versions." Glaxo is requesting that the stay of approvals "remain in effect until July 19, 1990. . . or until a final monograph is adopted setting forth all specifications and methods necessary for the characterization of the strength, quality, and purity of ceftazidime, whichever comes later." At a minimum, the petition requests "an interim stay of" approvals "for 90 days on the condition that petitioner promptly apply for a preliminary or permanent injunction preventing such approvals."
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