Sulfonylurea News and Research

RSS

NDA for Exenatide once weekly accepted for FDA review

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).

7 Jul 2009

Comprehensive review on sulfonylureas in the latest issue of Diabetic Hypoglycemia

The latest issue of the online journal Diabetic Hypoglycemia features an authoritative review on sulfonylureas by Professor Ian Campbell, a leading expert in oral hypoglycemia therapy.

4 Jun 2009

Drugs may be 'magic bullet' for infants born with rare form of diabetes

Infants born with a rare form of inherited diabetes might avoid irreversible damage to their pancreases if they are treated immediately with sulfonylurea drugs rather than insulin, according to a new report in the February 4th issue of Cell Metabolism , a Cell Press publication.

3 Feb 2009

Amylin, Lilly update on FDA review of Byetta (exenatide) injection monotherapy submission

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company have announced that the U.S. Food and Drug Administration (FDA) is continuing with its review of the regulatory application for use of Byetta (exenatide) injection as stand-alone therapy (monotherapy) in people with type 2 diabetes who are not achieving acceptable blood sugar control.

8 Dec 2008

GlaxoSmithKline believes there is no liver safety issue with Avandia (rosiglitazone maleate)

GlaxoSmithKline today issued the following response to a petition filed by Public Citizen to the U.S. Food and Drug Administration (FDA) on Avandia (rosiglitazone maleate), a highly effective therapy for treating type 2 diabetes when used in the appropriate patient population.

31 Oct 2008

FDA continues review of Takeda's NDA for Alogliptin

Takeda Pharmaceutical Company Limited has announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

12 Oct 2008

Warning issued on dangers of diabetes drug Avandia

Thousands of Australians who are taking the diabetes drug Avandia (rosiglitazone) have been urged by the drug's manufacturer to see their doctors following safety issues concerning the medication.

20 Aug 2008

Latest research suggests tight glucose control for diabetics

It has been found that keeping tight control of blood sugar levels in type 2 diabetics reduces the risk of kidney disease by 21 percent, and that weight gain, the use of multiple drug combinations and getting blood sugar too low, too quickly may all have been factors in causing early deaths.

9 Jun 2008

Tredaptive and Janumet recommended for approval in European Union

Food and Drug Administration (FDA) is currently reviewing the combination of extended release (ER) niacin and laropiprant under the trademark Cordaptive (ER niacin/laropiprant). The CHMP recommendation does not apply to regulatory decisions by the FDA and no inferences should be made about pending FDA regulatory actions based on the recommendation of the CHMP.

24 Apr 2008

Study shows Actos prevented progression of atherosclerotic plaque volume in patients

New data from a clinical trial using intravascular ultrasound (IVUS) technology found that in patients living with type 2 diabetes, ACTOS (pioglitazone HCl) reduced the atherosclerotic burden in the coronary arteries compared to glimepiride, and prevented progression compared to baseline.

1 Apr 2008

For safety, NHLBI changes intensive blood sugar treatment strategy in trial of diabetes and cardiovascular disease

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped one treatment within a large, ongoing North American clinical trial of diabetes and cardiovascular disease 18 months early due to safety concerns after review of available data, although the study will continue.

6 Feb 2008

Caraco Pharmaceutical Labs announces FDA approval to market generic Metaglip

Caraco Pharmaceutical Laboratories, Ltd., has announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Glipizide/Metformin Hydrochloride Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg (Glipizide/Metformin HCl).

15 Jan 2008

Takeda submits NDA for Alogliptin (SYR-322) in the U.S.

Takeda Pharmaceutical Company Limited (Takeda) has announced that Takeda Global Research & Development Center, Inc. submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for alogliptin (development code: SYR-322), a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes.

7 Jan 2008

GlaxoSmithKline response to JAMA article on ICES retrospective analysis

The following is GlaxoSmithKline's response to the retrospective analysis by the Institute for Clinical Evaluative Sciences (ICES) titled "Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes".

13 Dec 2007

GlaxoSmithKline implements changes to the US product label for Avandia

GlaxoSmithKline announced today that it is implementing changes to the US product label for Avandia(R) (rosiglitazone maleate), based on an extensive and thorough review by the FDA of myocardial ischemia data on Avandia, the most widely studied oral anti-diabetic medicine available.

15 Nov 2007

FDA adds warning for heart attacks to type 2 diabetes drug Avandia

The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

14 Nov 2007

Impact of various diabetes treatments on patients' health after heart attack.

Mayo Clinic researchers helped clarify a growing concern about the link between diabetes mellitus treatments and heart attack with the first large, population-based study showing that a group of common medications does not reduce diabetic patients' heart attack survival rates.

6 Nov 2007

Benefit of exenatide has not yet been proven

Since May 2007, a new drug has been available for the treatment of patients with diabetes mellitus type 2 in Germany: exenatide (trade name: Byetta), which is marketed by the manufacturer Eli Lilly.

18 Oct 2007

ACTOS associated with reduced risk of heart attack and stroke in patients with type 2 diabetes

Results presented at the 43rd Annual Meeting of the European Association for the Study of Diabetes demonstrate the ability of ACTOS (pioglitazone HCl) to reduce the risk of ischemic cardiovascular disease in patients with type 2 diabetes.

20 Sep 2007

GlaxoSmithKline responds to Journal of the American Medical Association articles

GlaxoSmithKline believes that conclusions drawn from the most recent meta-analyses published by Drs. Nissen et. al. and Furberg et. al. in the Journal of the American Medical Association do not confirm a difference in the safety profile of Avandia (rosiglitazone) and Actos (pioglitazone).

12 Sep 2007