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Pharma  News  Story
Astellas' US sub withdraws petition against FDA

Singapore, Nov 27, 2009: Astellas Pharma's US subsidiary has dismissed its lawsuit against the Food and Drug Administration (FDA).

In August this year, Astellas Pharma US had filed the lawsuit against the FDA after FDA substantially denied the company’s Citizen Petition regarding the safe and effective use of oral immunosuppressants used in organ transplant patients.

A Citizen Petition is a formal request asking FDA to issue, change or cancel a regulation, or to take other actions under the laws administered by the agency. FDA receives about 200 petitions yearly.

© BioSpectrum Bureau
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