Astellas has received the notice that FDA has substantially denied the company’s Citizen Petition, which had been submitted on September 2007, to ensure the safe and effective use of oral immunosuppressants used in organ transplant patients on 10 August, 2009.
Reportedly, in response to that, Astellas has filed a complaint in the US District Court in Washington, DC challenging FDA’s decision. The company requested the court to issue a Preliminary Injunction and Temporary Restraining Order, enjoining FDA’s approval of ANDA for oral immunosuppressant on 11 August, 2009.
Astella is a US affiliate of Tokyo-based Astellas Pharma. In the US, Astellas markets products in the areas of Immunology, Urology, Anti-Infectives, Cardiovascular and Dermatology.