Content about Thiazolidinediones

April 10, 2014

Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths.

MUMBAI and BALTIMORE — Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths. The product is the generic version of Actos tablets from Takeda Pharmaceuticals.

The drug is used an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. Actos tablets had annual sales in the United States of approximately $236 million as of December 2013, according to IMS MAT data. 

 

November 25, 2013

Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

SILVER SPRINGS, Md. – Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

June 19, 2013

Three new drugs for Type 2 diabetes made by Takeda Pharmaceutical have become available in pharmacies, the company said.

DEERFIELD, Ill. — Three new drugs for Type 2 diabetes made by Takeda Pharmaceutical Co. have become available in pharmacies, the company said.

The drug maker announced the availability of Nesina (alogliptin), Kazano (alogliptin; metformin hydrochloride) and Oseni (alogliptin; pioglitazone).

June 10, 2013

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

June 7, 2013

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

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

February 19, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

HYDERABAD, India — The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.

February 8, 2013

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

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.

January 28, 2013

The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said Friday.

The FDA announced the approval of Nesina (alogliptin), Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone) tablets.

Alogliptin is a new active ingredient, while metformin and pioglitazone are drugs already on the market.

November 15, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


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.



 

October 29, 2012

The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

PARSIPPANY, N.J. – The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

Watson announced the launch of 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 ended in August, according to IMS Health.

October 24, 2012

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.

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).

October 23, 2012

A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda's Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths.

August 27, 2012

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

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.

August 17, 2012

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

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.

September 16, 2011

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.

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.

July 26, 2011

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.

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.

July 14, 2011

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.

June 17, 2011

The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.

May 19, 2011

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.

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.

April 12, 2011

A point-of-sale safety check may reduce the risk of patients unsafely receiving a drug for Type 2 diabetes that may increase their risk of heart attack, according to a new study conducted by pharmacy benefit manager Prime Therapeutics and scheduled for presentation at the 23rd annual meeting of the Academy of Managed Care Pharmacy in Minneapolis.

ST. PAUL, Minn. — A point-of-sale safety check may reduce the risk of patients unsafely receiving a drug for Type 2 diabetes that may increase their risk of heart attack, according to a new study conducted by pharmacy benefit manager Prime Therapeutics and scheduled for presentation at the 23rd annual meeting of the Academy of Managed Care Pharmacy in Minneapolis.

March 25, 2011

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.

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.

March 18, 2011

With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

LONDON — With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

January 17, 2011

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

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.

January 17, 2011

Japanese drug maker Takeda Pharmaceutical has signed an agreement with Durham, N.C.-based Zinfandel Pharmaceuticals to develop a test for assessing Alzheimer’s disease risk in adults, the two companies said.

OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical  has signed an agreement with Durham, N.C.-based Zinfandel Pharmaceuticals to develop a test for assessing Alzheimer’s disease risk in adults, the two companies said.

September 22, 2010

The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes...

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.