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Executive Summary

BOLAR WILL SUBMIT NEW ANDA FOR GENERIC VERSION OF DYAZIDE, possibly before the end of April, if results of a study underway show bioequivalence, according to the company. The bioequivalence study data is currently being analyzed, and the company expects to have the results within a month. Bolar informed FDA on March 1 that it was withdrawing its request for a hearing on the agency's proposed withdrawal of the ANDA for triamterene 50 mg/hydrochlorothiazide 25 mg. The firm's letter, however, was received after FDA Acting Commissioner Benson already signed off on an official notice denying the company a hearing and withdrawing the company's ANDA. The notice, signed on Feb. 28, was published in the March 13 Federal Register. The ANDA withdrawal notice, which was effective March 13, denies Bolar a hearing on grounds that the firm "failed to raise a genuine and substantial issue of fact requiring a hearing." In proposing to withdraw the Bolar ANDA last November, FDA said that the company had made untrue statements to the agency and that there were discrepancies in Bolar's ANDA. In addition, FDA said that new test data raised questions about the reliability and adequacy of data submitted by the firm in its ANDA. In response to that notice, the agency said Bolar requested a hearing but "did not contest any of [FDA's] findings that the company's ANDA contained untrue statements and that results of new test information obtained by FDA raised further questions about the reliability of data." Bolar had argued that all questions about the bioequivalence of its product to SmithKline's innovator product would be answered by the new bio study, and that FDA should delay action until the results of the study were submitted. FDA, however, concluded that the upcoming bio study "does not warrant holding the withdrawal action in abeyance." FDA said that the new bio study "will not, in and of itself, cure the problems with Bolar's ANDA." The ANDA "contains so many critical falsehoods and discrepancies that the entire contents of the submission are in question," FDA explained. Bolar recalled its generic version of Dyazide on Jan. 31, one week after Rep. Dingell (D-Mich.) asked the firm to recall the product and forfeit its ANDA ("The Pink Sheet" Feb. 5, p. 14). Dingell's request was based on an admission by Bolar's counsel that information submitted by the company in support of its ANDA may have been false.

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