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SCHEIN SULINDAC SHIPMENTS WILL BEGIN WEEK OF APRIL 9

Executive Summary

SCHEIN SULINDAC SHIPMENTS WILL BEGIN WEEK OF APRIL 9, following the April 3 expiration of Merck's patent on the nonsteroidal anti-inflammatory (Clinoril). Schein subsidiary Danbury Pharmacal obtained prospective ANDA approval for the drug (pending expiration of the patent) in March 1988. Based on average wholesale price figures, Schein appears to be selling its product at a 12-13% discount to Clinoril. The average wholesale price for Schein's sulindac is $71.50 for 100 150 mg tabs and $87.90 for 100 200 mg tabs. The listed AWP for Merck's Clinoril is $82.01 for 100 150 mg tabs and $100.79 for 100 200 mg tabs. Schein said it hopes to capture 40-50% of the $200 mil.-plus sulindac market with its product. Schein is one of only two companies that received ANDA approval for the NSAID. The other company, American Therapeutics, had its ANDAs rescinded by FDA on April 2, because of what the agency described as "discrepancies" in the firm's marketing applications. In the April 2 letter to American Therapeutics, FDA Office of Generic Drugs Acting Director Bruce Burlington, MD, explained that the agency was rescinding its ANDA approval letters for the 150 and 200 mg tablet products because "inspection of your drug manufacturing establishment in Bohemia, New York [in March] revealed serious unexplained discrepancies between manufacturing records submitted to the FDA in the ANDAs and underlying records at your firm upon which the submissions were based." For example, FDA cited discrepancies between batch records and lab data for R&D lot testing and analysis. The agency also cited a number of instances where batch record information did not match information in equipment cleaning and usage records, for items such as when tableting began. Because of these discrepancies, FDA said, "we conclude that the records of the biobatch are not reliable. We therefore can no longer conclude that the manufacturing procedures to be used in commercial production are consistent with those used in a batch that has been shown bioequivalent to the listed drug." Therefore, FDA continued, "the agency hereby rescinds the letters of May 23, 1988, in which the agency announced that the applications were approved." * American Therapeutics is reportedly seeking a temporary restaining order against the agency's ANDA rescission, arguing that it has been denied due process. The company previously sued FDA when the agency revoked its ANDA for chlorzoxazone without formal notice ("The Pink Sheet" Aug. 14, p. 3). American Therapeutics former President and CEO Raju Vegesna and former consultant Mohammed Azeem have both pleaded guilty to giving illegal gratuities to FDA reviewers (see following T&G).
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