Content about Thiazolidinedione

August 15, 2012

Watson Pharmaceuticals is suing the Food and Drug Administration, alleging that an agency decision would improperly delay its release of a generic drug for diabetes, the company said Wednesday.

PARSIPPANY, N.J. — Watson Pharmaceuticals is suing the Food and Drug Administration, alleging that an agency decision would improperly delay its release of a generic drug for diabetes, the company said Wednesday.

July 30, 2012

Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

DEERFIELD, Ill. — Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

Takeda announced the resubmission to the Food and Drug Administration of applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in the Takeda drug Actos.

April 26, 2012

The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.

May 13, 2011

According to a report in the May issue of Cell Metabolism, while drugs known as thiazolidinediones, or TZDs, are widely used in diabetes treatment, they have effects on the kidneys that lead to fluid retention as the volume of plasma in the bloodstream expands.

MARYLAND HEIGHTS, Mo. — According to a report in the May issue of Cell Metabolism, while drugs known as thiazolidinediones, or TZDs, are widely used in diabetes treatment, they have effects on the kidneys that lead to fluid retention as the volume of plasma in the bloodstream expands.

"TZDs usually increase body weight by several kilograms," stated George Seki of the University of Tokyo. "However, TZDs sometimes cause massive volume expansion, resulting in heart failure."

February 14, 2011

GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.

The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.

February 22, 2010

The Food and Drug Administration is reviewing data from a large clinical study of a...