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Executive Summary

Bolar recalled its generic version of SmithKline's Dyazide and its extended release phenytoin (Parke-Davis' Dilantin) down to the retail level on Jan. 31. In a letter to its customers Bolar said it "is voluntarily recalling all lots" of triamterene 50 mg/hydrochlorothiazide 25 mg capsules and of phenytoin sodium 100 mg extended release capsules. The firm added that its distributors are requested and "authorized to extend this recall to your customers." In a Jan. 31 press release, Bolar said it notified FDA one day earlier "that it ceased production and distribution" of its generic Dyazide. The firm said it "had ceased distribution of phenytoin in December 1989." Bolar acknowledged publicly and to its customers that the recalls were necessary because the products' "bioequivalence cannot be assured." The company admitted the existence of "serious questions concerning the accuracy and reliability of the documentation supporting the approval of the ANDAs for these products." The press statement notes that "Bolar is currently engaged in conducting new bioequivalence studies for both products and intends to submit the results of these studies to the FDA when they are completed." However, the firm cautioned, the results will not be available "for at least two months." In a disclaimer similar to those included in SEC filings, Bolar noted that there is "no assurance" that the studies "will establish bioequivalency or, even if they establish bioequivalency, that the products will be reapproved for sale by the FDA." Furthermore, there is "no assurance" that "there will be a market for these products," if reapproved. Bolar estimated its 1989 net sales at $133 mil., of which generic Dyazide sales "accounted for approximately 38%" and phenytoin sales "accounted for approximately 2%." The two products, Bolar said, "would have accounted for approximately 52% of the company's income before taxes and extraordinary items for 1989, with Bolar's generic version of Dyazide accounting for substantially all of this percentage." The products represented the only generic versions of Dyazide and long-acting phenytoin on the market. Although the ANDAs have not yet been withdrawn, Bolar said it "cannot at this time anticipate when or whether it will be able to resume sales of its generic version of Dyazide." The loss of the product's sales "will have a material adverse effect on earnings, Bolar said, adding that it is "continuing" its "internal investigation" and "will continue to take appropriate action." Bolar's announcement reverses the company's position of eight days earlier. Bolar had said generic Dyazide would stay on the market pending the outcome of the ongoing bioequivalence testing ("The Pink Sheet" Jan. 29, p. 5). In a Jan. 19 letter to FDA, Bolar's outside counsel Eugene Pfeifer (King & Spalding) had asked FDA to delay scheduling a hearing on the agency's proposal to withdraw the generic Dyazide ANDA until the bio study was completed. The study, which has been in progress for several weeks, is being conducted at the University of California-San Francisco's School of Pharmacy. The study consists of a four-treatment crossover design in which 36 healthy males receive Bolar's generic Dyazide and the brandname drug. If the tests showed Bolar's drug to be bioinequivalent, Pfeiffer said that the company was "prepared to voluntarily withdraw the ANDA, thus mooting the issue of whether a hearing should be granted." On the other hand, if bioequivalence is established, he added, "Bolar would expect the proposal to withdraw the ANDA to be rescinded and for FDA to address remaining GMP issues, if any, through routine administrative mechanisms." In the Jan. 19 letter, Pfeifer also said that neither he nor his firm was aware of the falsity of Bolar documents used in a Sept. 11 submission to support the ANDA for generic Dyazide. The documents were submitted to FDA to demonstrate "that the product approved by FDA was the same product found to be bioequivalent by the testing laboratory," he noted. It has been alleged that Bolar disguised SmithKline's Dyazide capsules as Bolar's test drug and that the contract lab unknowingly tested the innovator product against itself.

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