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Executive Summary

BOLAR AGREES TO EXTEND NITROFURANTOIN RECALL TO RETAIL LEVEL following a meeting with FDA, the agency said in an Oct. 27 Talk Paper. Bolar voluntarily initiated a recall of its generic version of Norwich Eaton's Macrodantin on Oct. 9 at the wholesale and distributor levels, but the company had balked at recalling the product from retail shelves ("The Pink Sheet" Oct. 16, p. 5). "On Oct. 25, after FDA presented additional sample evidence from a second laboratory, Bio-research Laboratories Ltd. of Quebec, to support its view that the brand name product and the generic were switched for testing, the firm agreed to extend the recall to pharmacies and other retail outlets," FDA said. Bolar President Robert Shulman stated in a Oct. 27 release: "The questions that have been raised regarding the bioequivalency of our nitrofurantoin macrocrystals . . . are being addressed in an intensive internal investigation. We have retained the law firm of King & Spalding to perform this investigation and to otherwise audit the company's operations." FDA informed the company on Oct. 13 that the agency was initiating withdrawal proceedings for Bolar's ANDAs for nitrofurantoin macrocrystals 50 and 100 mg caps, based on information from sample analyses that raised questions about the validity of bioequivalence testing for the products. The agency also has indicated its intention to withdraw Bolar's ANDA for generic Dyazide. The Talk Paper notes that "FDA has downgraded the product's" therapeutic equivalence rating to "BX" (inequivalent) in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"). Nitrofurantoin is one of several Bolar products that FDA has referred to the HHS Inspector General's office to determine if ANDA submissions were based on fraudulent data. In addition to nitrofurantoin, the IG is investigating Bolar's ANDAs for generic Dyazide and Mellaril (thioridazine). Three other products are also being looked at by the IG, according to FDA sources.

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