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SILVER SPRING, Md. - The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

The FDA approved Macleods' pioglitazone hydrochloride tablets in the 15 mg, 30 mg and 45 mg strengths.

The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period that ended in August 2012, according to IMS Health.

FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.


The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.



PITTSBURGH — Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

The generic drug maker said it filed a motion in the U.S. District Court for the District of Columbia Tuesday to stay the court's order, which called on the FDA to let Watson launch a generic version of Takeda's Type 2 diabetes drug Actos (pioglitazone).

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic version of a diabetes drug made by Takeda, the agency said Friday.

LISBON, Portugal — A drug made by Boehringer Ingelheim and Eli Lilly showed "meaningful and durable" reductions in blood sugar in adults with Type 2 diabetes, according to results of a late-stage clinical trial presented Friday at a conference in Europe.

OSAKA, Japan — Two diabetes drugs made by Takeda Pharmaceutical Co. have been pulled from the market in France due to evidence that their use may increase the risk of bladder cancer, Takeda said.

Takeda said its French subsidiary, Laboratoires Takeda, would withdraw Actos (pioglitazone) and Competact (pioglitazone and metformin). In addition, Takeda said it was cooperating with the European Medicines Agency in a pan-European of pioglitazone. Competact is marketed in the United States under the brand name Actoplus Met.

SILVER SPRING, Md. — A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

SAN ANTONIO — A drug for Type 2 diabetes made by Takeda Pharmaceutical taken in the morning prevented the disease from developing in nearly three-quarters of patients who were at risk, according to a new study in the New England Journal of Medicine.

Researchers enrolled 602 patients through the University of Texas Health Science Center San Antonio and seven other centers and administered Actos (pioglitazone) to them, finding that it prevented Type 2 diabetes in 72% of those whose obesity, ethnicity and other factors put them at risk for the disease.

LONDON — Drug maker GlaxoSmithKline will take a legal charge of $3.4 billion related to its promotion of a controversial diabetes drug.

The British company said the charge related to an investigation by the U.S. Attorney’s Office for the District of Colorado regarding sales and promotion of the drug Avandia (rosiglitazone) in spite of reports of the risk of heart attacks in patients taking it.

SILVER SPRING, Md. The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes drug made by GlaxoSmithKline.

The agency said Thursday that it would restrict access to the Type 2 diabetes medication Avandia (rosiglitazone) in response to clinical study data suggesting that its use can increase the risk of heart attacks and strokes.