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Executive Summary

FDA is basing its efforts to withdraw Bolar's ANDA for its generic version of Dyazide on "new information" discovered by FDA investigators that casts doubt on the truthfulness of Bolar's ANDA. In a Notice of Opportunity for a Hearing, to be published in the Nov. 20 Federal Register, FDA says it is proposing to withdraw Bolar's ANDA because: "(1) the application contains untrue statements of material fact, and (2) based on new information . . . there is a lack of substantial evidence that the drug will have the effect it purports . . . to have under the conditions of use . . . suggested in its labeling." Bolar will have 30 days from the date of publication of the Federal Register notice to request a hearing and 60 days to supply FDA with data and information in support of its request for a hearing. Bolar said it is evaluating how it will respond to the notice. FDA notified Bolar in late August that the agency planned to initiate withdrawal proceedings for Bolar's triamterene 50 mg/hydrochlorothiazide 25 mg and to reduce the drug's bioequivalence rating to "BX" status. In October, FDA downgraded the product's equivalence rating. FDA Commissioner Young declared before Rep. Dingell's Nov. 17 hearing on the generic scandal that "the case of Bolar . . . goes to the very heart" of the congressman's fraud investigation. Young said FDA had "very compelling evidence" of fraud in Bolar's generic Dyazide ANDA. In the notice, FDA lists a number of discrepancies discovered by investigators in Bolar's ANDA. According to FDA, Bolar's batch records for the product used in bioequivalence studies (RD0054) date the firm's receipt of the raw material lots for both triamterene and hydrochlorothiazide after the raw materials were supposedly used in the manufacture of the finished product. Bolar later informed FDA that a handwritten version of the batch record for lot RD0054, which was not included in the ANDA, lists different raw material numbers than those in the typed version, but does not date when the materials were received. The one-page handwritten batch record, "purportedly the original" batch record, does not include information about "many" production and control operations, FDA states. However, the agency points out that the five-page typed batch record submitted with the ANDA contains entries that "are questionable and cannot be relied upon to establish methods of manufacture of the batch." FDA notes that "reportedly" the typed batch record was prepared by a Bolar employee, Susan Long, "sometime after" lot RD0054 was made, and the still uncompleted record was sent to two other Bolar employees, A. Walsh and T. Vahidy, who completed sections of the production order and backdated the document to when the batch was made. The notice also reiterates FDA's difficulty in determining whether lot RD0054 was actually used in the bioequivalence tests conducted by PharmaKinetics. "In the absence of reliable data demonstrating acceptable stability, dissolution and bioequivalence to the listed drug, there is a lack of substantial evidence of effectiveness," the notice states. Bolar is currently conducting another bioequivalence study for its generic version of Dyazide at the University of California-San Francisco in the hopes that it can submit the data to FDA before the ANDA is revoked. Bolar's generic Dyazide may be the first of several of the firm's generic products to be removed from the market. FDA has informed Bolar that it plans to begin withdrawal proceedings for the company's generic version of Macrodantin. In addition, FDA sources say that information on four other Bolar generic products has been passed to the HHS Inspector General's office for investigation into further wrongdoing.

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