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Executive Summary

ELKINS-SINN SUPPLEMENTAL NDA FILINGS REQUIRED FOR PRODUCTS MANUFACTURED in a new facility, FDA told the firm in a recent meeting. According to FDA minutes of the meeting, FDA Office of Compliance Deputy Director Sammie Young stated that all products produced in a new facility adjoining Elkins-Sinn's pre-existing site are in violation of the FD&C Act. Young requested that the firm "immediately cease shipment" of the products until necessary supplements have been approved by the agengy. Elkins-Sinn has since filed the requested supplements with FDA, a Robins spokesman said. According to the FDA memorandum of the meeting, Elkins-Sinn Scientific Affairs VP Davis Reese explained that the firm's decision not to submit supplements for NDA and ANDA products produced at the new site was "a conscious decision. . . based on perceived precedent justifying that position." Reese said everything that would have been submitted in support of a supplement had been done by the company. The memo noted that Reese and others "raised the possibility that because Elkins-Sinn holds a major market share for heparin and is the sole supplier of another drug, Reglan, the public could suffer due to shortages." Therefore, "it was agreed that Elkins-Sinn will prepare a list prioritizing supplements and that the Center ]for Drugs & Biologics[ will work with the firm, insofar as possible, to avoid any negative impact on consumers," the memo stated. Robins said that Reglan was not affected by FDA's decision to require supplemental NDA filings for products to be manufactured in the new plant. For the products awaiting agency approval of the supplemental filings, Robins said it has shifted manufacturing to the old plant and should be able to meet "most sales demands."

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