Astellas announced it has submitted a New Drug Application (NDA) to the FDA seeking approval for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant ...
Astellas Announces FDA Approval of ASTAGRAF XL™ (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection in Adult Kidney Transplant Recipients NORTHBROOK, Ill., July 19, 2013 ...
Biocon is offering tacrolimus capsules, following the Food and Drug Administration’s approval in November. The product is an immunosuppressant used in the treatment of organ transplant patients, which ...
NORTHBROOK, Ill., Dec. 4, 2012 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug ...
Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, "Astellas") is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus ...
The FDA reduced its therapeutic equivalence rating in Accord Healthcare’s tacrolimus oral capsules because of safety concerns, but the generic’s approval remains, the agency said Sept. 19. Tacrolimus ...
Astellas announced that the FDA has accepted for review the company’s New Drug Application (NDA) for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney ...
Lupin is introducing tacrolimus capsules in dosage strengths of 0.5 mg, 1 mg, and 5 mg. The product is the generic of Astellas’ Prograf capsules. It is indicated for the prophylaxis of organ rejection ...
On January 19, 2006, the US Food and Drug Administration (FDA) announced the approval of revisions to the safety labeling for the 2 topical calcineurin inhibitors, pimecrolimus cream (Elidel) and ...
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