Oral Medication | Page 8 of 11

Santarus to Launch Novel Type 2 Diabetes Drug CYCLOSET

San Diego based Santarus, a biopharmaceutical company, announced the commercial U.S. launch of CYCLOSET (bromocriptine mesylate) tablets. CYCLOSET is a FDA approved prescription drug to improve glycemic control in adults with type 2 diabetes mellitus both as monotherapy and in combination with other oral antidiabetic agents...

KOMBIGLYZE XR Approved for the Treatment of Type 2 Diabetes

Bristol-Myers Squibb Company and AstraZeneca announced FDA approval of KOMBIGLYZE™ XR, the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet for the treatment of type 2 diabetes in adults. KOMBIGLYZE XR offers...

FDA to Introduce New Restrictions on Avandia Use

Following an ongoing FDA review of the diabetes drug Avandia (rosiglitazone) the FDA will require that GlaxoSmithKline (GSK) develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class...

Boehringer Ingelheim Presents New Studies at EASD Annual Meeting

This week at the 46 th Annual Meeting of the European Association for the Study of Diabetes (EASD) Boehringer Ingelheim presented data from its linagliptin phase III clinical trial. Linagliptin belongs to the novel class of DPP-4 inhibitors and is currently...

New Investigational Drug Improved HbA1c in Adults with Type 2 Diabetes

Bristol-Myers Squibb Company and AstraZeneca announced results from a randomized, double blind Phase 3 clinical study, which demonstrated that the addition of the investigational drug dapagliflozin to existing glimepiride (sulphonylurea) therapy produced significant reductions in HbA1c in adult patients with type 2 diabetes compared to glimepiride alone...

Actos Ongoing FDA Safety Review: Potential Increased Risk of Bladder Cancer

The FDA notified healthcare professionals and patients that the Agency is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone) is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study. At this time, FDA has not concluded that Actos increases the risk of bladder cancer...

Santarus Licenses Novel Type 2 Diabetes Drug CYCLOSET

Santarus, Inc., S2 Therapeutics, Inc. and VeroScience LLC announced that they have entered into a distribution and license agreement granting Santarus exclusive rights to manufacture and commercialize CYCLOSET(R) (bromocriptine mesylate) tablets in the U.S. CYCLOSET is a prescription drug...

Actos as Dangerous as Avandia, New Study Shows

The continuing controversy surrounding the cardiovascular risk of GlaxoSmithKline's diabetes drug Avandia has led to sharp declines in its use and a surge in sales of the competing drug, Actos. Although the drugs are similar and both had FDA warnings in 2007, Takeda's Actos has been...

GSK Halts Enrollment in Avandia Study at FDA Request

GlaxoSmithKline confirmed today that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA review of recommendations from its Advisory Committee meeting July 13-14...

GlaxoSmithKline Issues Statement in Response to FDA Advisory Committee Vote on Avandia

GlaxoSmithKline confirmed that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow the diabetes drug Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions...