Content about Macrolides

January 21, 2014

Greenstone, a U.S.-based generic pharmaceutical subsidiary of Pfizer, on Tuesday announced the introduction of Sirolimus to its generic pharmaceutical product line.

PEAPACK, N.J. — Greenstone, a U.S.-based generic pharmaceutical subsidiary of Pfizer, on Tuesday announced the introduction of Sirolimus to its generic pharmaceutical product line. The product is offered in dosage strengths of 0.5mg x 100. 

Greenstone’s Sirolimus product is the authorized generic of, and equivalent to, Pfizer's Rapamune (sirolimus). 

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.

April 27, 2012

A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

EAST HANOVER, N.J. — A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

The FDA approved Afinitor (everolimus) tablets for treating the tumors, known as renal angiomyolipomas, in adults with TSC who don't require surgery. The drug already was approved to treat brain tumors known as subependymal giant cell astrocytoma, or SEGA, in patients with TSC.

January 27, 2012

The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

October 5, 2011

The Food and Drug Administration has accepted a regulatory approval application from Merck and Ariad Pharmaceuticals for a new drug to treat soft-tissue and bone cancers, the drug makers said Wednesday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application from Merck and Ariad Pharmaceuticals for a new drug to treat soft-tissue and bone cancers, the drug makers said Wednesday.

The FDA is expected to complete its review of ridaforolimus for soft-tissue and bone sarcomas in patients who have shown a favorable response to chemotherapy by second quarter 2012.

Sarcomas are cancers of the body's connective tissues, and treatment options remain limited, the companies said.

June 30, 2011

Canadian drug maker Valeant Pharmaceuticals International will acquire rights to topical drugs for eczema and cold sores from Swedish drug maker Meda.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals International will acquire rights to topical drugs for eczema and cold sores from Swedish drug maker Meda.

Valeant said it would buy rights for the eczema drug Elidel (pimecrolimus) and the cold sore drug Xerese (acyclovir and hydrocortisone) for the United States, Canada and Mexico. Valeant said, however, that Xerese has not yet received regulatory approval in Canada.

May 6, 2011

The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

Novartis announced the approval of Afinitor (everolimus), saying it marked the first approval of a drug for advanced pancreatic NET in nearly 30 years. The drug already is approved for treating cancers of the kidneys and brain.

February 11, 2011

The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

SILVER SPRING, Md. —The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

Zortress is a drug used to prevent rejection of transplanted kidneys.

“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” FDA Center for Devices and Radiological Health director Jeffrey Shuren said.

October 31, 2010

The Food and Drug Administration has approved a cancer drug for treating tumors associated with...

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...