Innovator Astellas announced (in a press release Here ) that U.S. District Court in Washington, D.C has refused preliminary injunction and temporary restraining order against USFDA’s approval of ANDA for Tacrolimus (Prograf) 0.5 mg, 1mg and 5 mg capsules.
Earlier, innovator informed about Citizen petition refusal by USFDA (in press release Here ). Subsequently, innovator challenged USFDA’s decision (as reported in the press release Here ) and filed a complaint in U.S. District Court in Washington, D.C. and requested the court to issue a preliminary injunction and temporary restraining order against USFDA’s approval of ANDA for Tacrolimus (Prograf) 0.5 mg, 1mg and 5 mg capsules.
As reported earlier by IP Pharm Doc Here, the product patent US4894366 expired on April 8, 2008. However, generic version were not approved immediately after the expiry of product patent, as innovator filed citizen petition against the generic approval.
Earlier, Innovator got final approval for 1 mg and 5 mg capsules on Apr 8, 1994 and for 0.5 mg capsules on Aug 24, 1998 for use of Tacrolimus (Prograf) in liver and kidney transplants.
Also, innovator secured Orphan Drug Exclusivity (ODE) in 2006 for new clinical indication, to prevent rejection of heart transplants. As per USFDA database, the said exclusivity would expire on March 29, 2013.
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