Astellas gets fifth action letter on modified-release tacrolimus
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Astellas Pharma receives another "approvable" letter for its once-daily formulation of its immunosuppressant Prograf (tacroliumus), dashing hopes of approval before a substance patent for the twice-daily formulation expired April 8. Prograf MR is under review for prophylaxis of organ rejection in both kidney and liver transplant patients. The Japanese firm received the second approvable letter for the liver transplant indication April 30; the kidney transplant indication got its second approvable letter in March. A heart transplant indication was deemed "not approvable" in January 2007. Astellas said it is "examining the future strategy" and working closely with FDA to better understand the issues raised. More time needed for Entereg review: After a three-month delay pushed back the user fee date for GlaxoSmithKline/Adolor's Entereg (alvimopan), FDA will not meet the scheduled May 10 action date, Adolor announces. After the Gastrointestinal Drugs Advisory Committee called the risk management plan inadequate in January, the firms submitted a new program in February. Entereg, indicated for postoperative ileus, has received two "approvable" letters since the NDA submission in 2004 (1Pharmaceutical Approvals Monthly November 2006, In Brief)
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Astellas Pharma receives another "approvable" letter for its once-daily formulation of its immunosuppressant Prograf (tacroliumus), dashing hopes of approval before a substance patent for the twice-daily formulation expired April 8. Prograf MR is under review for prophylaxis of organ rejection in both kidney and liver transplant patients. The Japanese firm received the second approvable letter for the liver transplant indication April 30; the kidney transplant indication got its second approvable letter in March. A heart transplant indication was deemed "not approvable" in January 2007. Astellas said it is "examining the future strategy" and working closely with FDA to better understand the issues raised. More time needed for Entereg review: After a three-month delay pushed back the user fee date for GlaxoSmithKline/Adolor's Entereg (alvimopan), FDA will not meet the scheduled May 10 action date, Adolor announces. After the Gastrointestinal Drugs Advisory Committee called the risk management plan inadequate in January, the firms submitted a new program in February. Entereg, indicated for postoperative ileus, has received two "approvable" letters since the NDA submission in 2004 (1 Pharmaceutical Approvals Monthly November 2006, In Brief). |