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BOLAR HAS RECEIVED 28 SUPPLEMENTAL NDA APPROVALS

Executive Summary

BOLAR HAS RECEIVED 28 SUPPLEMENTAL NDA APPROVALS during the last four weeks, including 12 in the last week, for reformulated products that the firm stopped marketing last August, Bolar told "The Pink Sheet." Approximately 45-50 supplemental NDAs have been filed, Bolar indicated. After mid-August meetings with FDA that were triggered by a May 7 reg letter, Bolar agreed to freeze inventories of 66 Rx drug dosage forms that had been reformulated and marketed without approved supplemental applications. "Bolar has received approval from the FDA to resume marketing substantially all of the major products withheld from sale since mid-August," the company announced in a Nov. 14 press release. "The FDA has either approved manufacturing change supplements for the products or has agreed with the company's position that additional approvals were not needed." The company said that in most cases it began shipping a specific product "within a day or two" after receiving FDA approval. According to the release, Bolar has received virtually no cancellations from its customers for outstanding orders and is now filling from its inventory the backlog created by the temporary suspension of shipments. The company said that it expects the backlog to be filled by the end of 1985.
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