Content about pioglitazone

PHILADELPHIA — A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

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.

JERUSALEM — Teva Pharmaceutical Industries announced the launch of an authorized generic of a Type 2 diabetes drug.

The company launched pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda Pharmaceuticals' Actos.

Annual sales of Actos in the United States were approximately $2.7 billion for the 12-month period ended in June, according to IMS sales data.

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.

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.

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 — Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

Takeda announced that it resubmitted its applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in Actos, which the FDA approved in 1999.

The FDA will review the applications over the next six months, the drug maker said.

Last month, the Food and Drug Administration approved Tradjenta (linagliptin), an oral Type 2 diabetes drug made by German drug maker Boehringer Ingelheim and Indianapolis-based Eli Lilly. The drug belongs to the class known as dipeptidyl peptidase-4 inhibitors, which also includes Merck’s Januvia (sitagliptin). With diabetes affecting some 26 million Americans and growing rapidly, Drug Store News spoke with Wa’el Hashad, BI’s VP cardiovascular and metabolic disorders marketing, about what the approval of Tradjenta means for the diabetes market.


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.