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Akorn Submits ANDA for FDC Ltd.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Akorn, Inc. has submitted the first ANDA with the Office of Generic Drugs on behalf of FDC, Ltd. (FDC). The two companies signed a purchase and supply agreement in July 2004. FDC is an Indian manufacturer and marketer of ophthalmic pharmaceutical products. The proposed drug product is an ophthalmic solution that will be manufactured by FDC in a blow-fill-seal container closure system.

FDC will develop, manufacture and supply finished dosage form drug products to Akorn, which is responsible for filing FDA regulatory submissions on behalf of FDC. Akorn has exclusive U.S. marketing rights to all drug products filed on behalf of FDC.

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