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Executive Summary

Bolar will be shipping previously reformulated products in their original, approved formulations to customers "within two weeks or so," a company spokesman told "The Pink Sheet." In a letter to its customers drafted Aug. 22, Bolar said it "is beginning immediately to manufacture and distribute such products in complete conformance with our NDAs as originally approved. We anticipate a minimum of disruption in the availability of the products to our customers." Following Aug. 16 and 21 meetings with FDA, Bolar agreed to freeze inventories of 66 Rx drug dosage forms that had been reformulated and marketed without approved supplemental applications. The stocks are reportedly worth approximately $1 mil. FDA agreed not to seize or order a recall of the reformulated products that were already in the distribution channels as of the close of business Aug. 16. The 66 products accounted for 40% of Bolar's 1985 business to date, the firm acknowledged. FDA issued Bolar a regulatory letter on May 7 after inspections of facilities in New Jersey and Puerto Rico revealed that certain inactive ingredients had been changed in a number of approved products. An official from FDA's Brooklyn District recommended seizure of the reformulated drugs. In its letter, Bolar emphasized that the reformulated products posed no safety or efficacy problems and that the reformulations were minor. "Neither the FDA nor Bolar feels that there is any compromise of the safety or efficacy of the products now in the marketplace." However, the letter states, "we are holding our inventory until such time as the applicable NDA supplements are approved." The company explained that the reformulations involved changes in "the ratios and amounts of inactive excipients" and were "brought about by the use of newer equipment, scale-up to larger size batches, U.S.P. changes in product specifications, color changes, etc." Bolar added: "The reformulated products always met all their quality control specifications; in vitro bioavailability was assured through comparative dissolution testing; and the stability of the products was determined." Reportedly, several of the changes will require new ANDAs. FDA issued a directive to its regional and district offices to "be alert during inspections to changes in manufacturing equipment or any other reason which may lead to formulation changes for approved drugs." The 66 affected Bolar products, include allopurinol, chlorpropamide, chlorthalidone, chlorothiazide, dexamethasone, dipyridamole, ergoloid mesylates, guanethidine, hydralazine, hydrochlorothiazide, hydroflumethiazide, isosorbide dinitrate, methocarbamol, nitrofurantoin, procainamide, and spironolactone.

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