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Last updated on April 17, 2014 at 10:41 EDT

Latest Mycophenolic acid Stories

2009-08-11 07:00:00

WALTHAM, Mass., Aug. 11 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the entry and uptake of premium-priced biologics will drive the systemic lupus erythematosus drug market to more than quadruple from approximately $420 million in 2008 to nearly $2 billion in 2018. The new Pharmacor report entitled Systemic Lupus Erythematosus finds that the primary drivers of market growth will be the entry...

2009-08-10 22:52:00

DEERFIELD, Ill., Aug. 10 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas") announced today that the U.S. Food and Drug Administration (FDA) has substantially denied the company's Citizen Petition to ensure the safe and effective use of immunosuppressants (also called anti-rejection medications) used to prevent rejection in organ transplant patients. In their petition, Astellas requested that the FDA take additional measures to protect transplant recipients, a unique and vulnerable...

2009-08-04 14:00:00

Underweight and very severely obese patients at riskA recent study by doctors at the University of Washington explained that patients who are significantly underweight or very severely obese prior to liver transplantation are at increased risk of death following transplantation surgery. These findings, from the largest known observation of liver transplantation at the extremes of BMI, are published in the August issue of Liver Transplantation, a journal published by John Wiley & Sons on...

2009-07-14 12:00:57

The U.S. Food and Drug Administration is ordering manufacturers of some immunosuppressant drugs used in kidney transplants to change their labeling. The FDA said the updated labels must reflect an increased risk of infections. The required label changes affect drugs used to help prevent rejection of transplanted organs. The drugs are Rapamune (sirolimus), Sandimmune (cyclosporine), and three generic drugs, Neoral (cyclosporine modified), Cellcept (mycophenolate mofetil) and Myfortic...

2009-05-28 08:00:00

DEERFIELD, Ill., May 28 /PRNewswire/ -- The Food and Drug Administration (FDA) has granted Astellas Pharma US, Inc. approval for the use of Prograf(R) (tacrolimus) in conjunction with mycophenolate mofetil (MMF) for the prevention of organ rejection in kidney transplant recipients. Prograf is a cornerstone therapy for preventing transplant rejection in liver, kidney and heart transplant recipients. The approval came on May 19, 2009 in response to a Supplemental New Drug Application (sNDA)...

2009-05-07 07:00:00

PITTSBURGH, May 7 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Mycophenolate Mofetil Tablets, 500 mg, and Mycophenolate Mofetil Capsules, 250 mg. Mycophenolate Mofetil is the generic name for Roche's CellCept(R), which is indicated for the prevention of organ rejection in patients receiving...

2009-05-04 11:19:00

COLUMBUS, Ohio, May 4 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the launch of its generic for Mycophenolate Mofetil 250mg Capsules and 500mg Tablets by the U.S. Food and Drug Administration. These products are available in 250mg Capsules Bottles of 100 and 500, 500mg Tablets Bottles of 100 and 500. These products are available for immediate shipment to wholesalers and pharmacies nationwide. (Photo: http://www.newscom.com/cgi-bin/prnh/20090504/CL10321) Roxane Laboratories'...

2009-02-18 08:00:00

Study Suggests Genetic Approach to Personalized Screening of Anti-Rejection Drug Dosing CINCINNATI, Feb. 18 /PRNewswire-USNewswire/ -- Screening for mutations in a gene that helps the body metabolize a kidney transplant anti-rejection drug may predict which children are at higher risk for side effects, including compromised white blood cell count or organ rejection, according to new research. Published online Feb. 18 by the Nature journal Clinical Pharmacology and Therapeutics, the study...

2008-09-05 09:00:08

Biotech company Pharming Group has announced that the FDA has authorized a clinical study with recombinant human C1 inhibitor for the treatment of antibody-mediated rejection in kidney transplantation. Hans Sollinger of the University of Wisconsin, Madison will conduct the clinical trial with recombinant human C1 inhibitor (rhC1INH) under an investigator IND from the FDA. Recombinant human C1 inhibitor is a key inhibitor of the classical complement system. In the planned study, rhC1INH...

2008-09-03 03:00:05

Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that the US Food and Drug Administration (FDA) has authorized a clinical study with recombinant human C1 inhibitor (rhC1INH) for the treatment of antibody-mediated rejection (AMR) in kidney transplantation. Dr. Hans Sollinger of the University of Wisconsin, Madison will conduct the clinical trial with rhC1INH under an Investigator IND from the FDA. Over 15,000 kidney transplants occur in...