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BOLAR NEGOTIATING WITH FDA ON AUDIT OF COMPANY’s ANDAs FOR NARROW THERAPEUTIC RANGE DRUGS; FIRM SUSPENDS DISTRIBUTION OF ENTIRE PRODUCT LINE FEB. 5

Executive Summary

Bolar is negotiating with FDA over an agency audit of the firm's ANDAs. The generic drug manufacturer met with FDA on Feb. 9 in an effort to pin down which of the firm's generic drugs should be included in a review of ANDAs. A week earlier, on Feb. 2, Bolar agreed to an audit by FDA of its narrow therapeutic range drugs for the treatment of critical conditions. Disagreement between Bolar and FDA over which products' ANDAs should be slated for evaluation has apparently delayed an announcement by the company of its arrangement with the agency. An FDA spokesperson said the agency is initiating an audit "not for any cause except that three of their drugs had false applications." The spokesperson added that FDA wants to be confident that "drugs with narrow therapeutic action are as they're supposed to be." Reportedly, FDA also would like independent bioequivalence studies to be conducted on some of the drugs. On Feb. 2, Bolar voluntarily agreed to suspend distribution of its entire product line, pending a mutual decision with FDA on which drugs will be audited. The temporary suspension of sales took effect on Feb. 5. According to FDA, once a list of specific drugs is drawn up, Bolar expects to reintroduce those products that will not be subject to the audit. Trading of Bolar's stock on the American Stock Exchange was halted on Feb. 7 by request of the company. At that time, the stock was trading at $13-1/8, up $1 from the previous day. However, the American Stock Exchange is understood to be concerned with Bolar's delay in calling a halt to the stock's trading pending the company's announcement of its agreement with FDA. In a prepared statement, the American Stock Exchange said that it "is devoting considerable resources in an effort to resolve the situation, and any future trading of the stock...must await the results of our inquiry as well as certain ongoing inquiries by other regulatory bodies." Trading in Bolar's shares was earlier halted from Jan. 25 to Feb. 3 in response to a request by House Energy & Commerce/Oversight Subcommittee Chairman Dingell (D-Mich.) that Bolar remove its generic Dyazide from the market because the company had allegedly filed false information in a submission to FDA for its generic Dyazide ("The Pink Sheet" Jan. 29, p. 5). Bolar subsequently recalled its generic version of Dyazide and its extended release phenytoin, explaining that "bioequivalence cannot be assured" ("The Pink Sheet" Feb. 5, p. 14). In addition, Rep. Dingell has asked the Securities & Exchange Commission to investigate the alleged dumping of Bolar stock by company officials on or about Dec. 18 and the failure of Bolar to disclose to the public information on the falsity of its submission in a timely manner. FDA embarked on an industry-wide review of generic and brandname narrow therapeutic range drugs last fall in an effort to deal with public safety questions arising from the generic drug scandal ("The Pink Sheet" Dec. 11, p. 3). FDA said that its analysis of these drugs, to determine whether they meet U.S. Pharmacopeia standards, is 90% complete and that results should be available this month. Apparently, FDA is using the public safety issue as a starting point for dealing with its concerns over the possibility that Bolar may have submitted fraudulent information in applications for its drugs. Of the 24 drugs with narrow therapeutic ranges that FDA is looking at in its industry-wide sampling program, Bolar has ANDAs for: clonidine, disopyramide, guanethidine, lithium carbonate, oxtriphylline, phenytoin, primidone, procainamide HCl, quinidine gluconate, and warfarin sodium. Separately, FDA announced in the Feb. 7 Federal Register that it is withdrawing the approval of Bolar's ANDAs for its generic nitrofurantoin 50 and 100 mg capsules. The notice states that "Bolar has requested that approval of the applications be withdrawn and has waived its opportunity for a hearing."

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