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Search Results for "Extended Release Tacrolimus"

18:10 EDT 18th May 2013 | BioPortfolio

Original Source: Once-Daily Prolonged-Release Tacrolimus (ADVAGRAF) Versus Twice-Daily Tacrolimus (PROGRAF) in Liver Transplantation.

The efficacy and safety of dual-therapy regimens of twice-daily tacrolimus (BID; Prograf) and once-daily tacrolimus (QD; Advagraf) administered with steroids, without antibody induction, were compared in a multicenter, 1:1-randomized, two-arm, parallel-group study in 475 primary liver transplant recipients. A double-blind, double-dummy 24-week period was followed by an open extension to 12 months posttransplant. The primary endpoint, event rate of biopsy-proven acute rejection (BPAR) at 24 weeks, was 33.7%...

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Astellas Submits U.S. New Drug Application for Tacrolimus Extended Release Capsules, a Prophylaxis of Organ Rejection in Transplant Recipients

NORTHBROOK, Ill., Sept. 24, 2012 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced it has subm...

Astellas Announces Acceptance of U.S. New Drug Application for Tacrolimus Extended Release Capsules

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 A...

Astellas seeks FDA approval for tacrolimus tablets

Astellas Pharma US has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for tacrolimus extended release capsules for the prophylaxis of organ reject...

Astellas Submits U.S. New Drug Application for Tacrolimus Extended Release Capsules, a ...

Astellas Announces Acceptance of U.S. New Drug Application for Tacrolimus Extended Release Capsules (pdf 42KB)

Astellas Submits U.S. New Drug Application for Tacrolimus Extended Release Capsules, a Prophylaxis of Organ Rejection in Transplant Recipients (pdf 32KB)

Astellas seeks FDA approval for tacrolimus NDA for prophylaxis of organ rejection

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval...

Sequential oral, topical tacrolimus benefits dermatitis

(HealthDay)—Sequential therapy with oral tacrolimus and topical tacrolimus may be an effective treatment for severe atopic dermatitis (AD), according to a pilot study published in the October issue...

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A comparison of the extended-release and standard-release formulations of tacrolimus in de novo kidney transplant recipients: a 12-month outcome study.

BACKGROUND: Limited comparative data are available on the outcomes between extended-release and standard-release tacrolimus when used de novo in kidney transplant recipients (KTRs). METHODS: We identi...

Pharmacokinetics of tacrolimus converted from twice-daily formulation to once-daily formulation in Chinese stable liver transplant recipients.

Aim:To evaluate the pharmacokinetics of tacrolimus in Chinese stable liver transplant recipients converted from immediate release (IR) tacrolimus-based immunosuppression to modified release (MR) tacro...

Pharmacokinetics for once-daily versus twice-daily tacrolimus formulations in de novo liver transplantation: A randomized, open-label trial.

Tacrolimus, a cornerstone immunosuppressant, is available as a twice-daily formulation (tacrolimus bid). A once-daily prolonged-release formulation (tacrolimus qd) has been developed. This 6-week, ran...

Comparison of release and penetration of tacrolimus ointment reference and trial formulation after dermal application to pigs by liquid chromatography-electrospray ionization tandem mass spectrometry.

To investigate the consistency and bioequivalence of tacrolimus ointment reference and trial formulation, the tacrolimus concentrations in blood and skin were determined by HPLC-ESI-MS/MS following to...

Novel gastroretentive sustained-release tablet of tacrolimus based on self-microemulsifying mixture: in vitro evaluation and in vivo bioavailability test.

Aim:To develop a novel gastroretentive drug delivery system based on a self-microemulsifying (SME) lipid mixture for improving the oral absorption of the immunosuppressant tacrolimus.Methods:Liquid SM...

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