Akron files first ANDA for India's FDC Ltd

27 August 2006

Specialty US pharmaceuticals firm Akorn says that it has submitted the first Abbreviated New Drug Application with the Office of Generic Drugs on behalf of FDC Ltd, India's second-largest manufacturer and marketer of ophthalmic pharmaceutical products. Akorn and FDC signed a purchase and supply agreement in July 2004. The proposed drug product is only identified as an ophthalmic solution that will be manufactured by FDC in a blow-fill-seal container closure system.

Arthur Przybyl, Akorn's chief executive, stated: "FDC will develop, manufacture and supply finished dosage form drug products to Akorn and we are responsible for filing Food and Drug Administration regulatory submissions on behalf of FDC. Akorn has exclusive US marketing rights to all drug products filed on behalf of FDC."

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