Content about Tacrolimus

August 22, 2013

Astellas Pharma has introduced a new drug for preventing the body from rejecting transplanted organs, the company said.

NORTHBROOK, Ill. — Astellas Pharma has introduced a new drug for preventing the body from rejecting transplanted organs, the company said Thursday.

The drug maker announced the availability of Astagraf XL (tacrolimus) extended-release capsules in pharmacies. The drug is designed for use in kidney transplant patients with Genenetech's CellCept (mycophenolate mofetil) and corticosteroids, with or without induction of Novartis' Simulect (basiliximab).

July 22, 2013

The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

Astellas announced through a U.S. subsidiary that the FDA had approved Astagraf XLTM (tacrolimus) extended-release capsules for preventing rejection of transplanted kidneys, for use with Genentech's CellCept (mycophenolate mofetil) and corticosteroids, with or without Simulect (basiliximab), a biotech drug made by Swiss drug maker Novartis.

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

September 26, 2012

The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.

NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.

Astellas Pharma US said it applied with the FDA for approval of tacrolimus extended-release capsules to prevent rejection of transplanted kidneys in adults and transplanted livers in men. The drug was approved in Europe in 2007 under the name Advagraf and under the name Graceptor in Japan in 2008; the drug has been approved in 69 countries so far.

August 13, 2012

An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

January 27, 2011

Swiss drug maker Novartis posted sales of $14.2 billion for fourth quarter 2010 and $50.6 billion for the year as a whole, according to an earnings report released Thursday.

BASEL, Switzerland — Swiss drug maker Novartis posted sales of $14.2 billion for fourth quarter 2010 and $50.6 billion for the year as a whole, according to an earnings report released Thursday.

That compared with sales of $12.9 billion and $44.3 billion during fourth quarter 2009 and 2009 as a whole, respectively. Profits for the year were nearly $10 billion, an 18% increase from $8.4 billion in 2009, though profits for the quarter decreased by 2%, from fourth quarter 2009’s $2.32 billion to $2.27 billion in fourth quarter 2010.

September 20, 2010

The Food and Drug Administration has approved a generic treatment for organ transplant patients....

PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.

 

Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.

 

 

July 5, 2010

The Food and Drug Administration has approved a drug made by Watson Pharmaceuticals for treating...

May 20, 2010

Dr. Reddy’s Labs has launched a treatment for organ transplant patients, the Indian generic drug...