Akorn submits ANDA with OGD
US drugmaker Akorn has submitted the first Abbreviated New Drug Application with the Office of Generic Drugs on behalf of the firm Serum Institute of India. Akorn and Serum announced the signing of an exclusive drug development and distribution agreement for 16 anticancer injectable products in October 2004. Since then, Serum has constructed and validated a dedicated, state-of-the art manufacturing facility for producing liquid and lyophilized oncolytic drug products.
The submitted ANDA is a drug product that is given as a treatment for many different types of cancer, and has an estimated US market size of around $53.0 million. Akorn expects to launch the drug product in 2010.
Arthur Przybyl, Akorn's chief executive, stated: "this drug application represents the initial expansion of our product pipeline into anti-cancer injectables. Our partnership with Serum also includes development projects for four vaccine products and a rabies monoclonal antibody."
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