FDA Rejects New Byetta Formula

The long-awaited long-acting version of Eli Lilly’s and Amylin Pharmaceuticals’ diabetes drug Byetta is delayed; FDA says they need answers to certain questions about the drug makers’ manufacturing processes and how it intends to mitigate health risks to users.

Submitted by Amy Tenderich

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Type 2 Diabetes Drug Alert

A safety review notice was issued by the Food and Drug Administration (FDA) on February 23 about rosiglitazone, a drug used in several popular oral diabetes medications

Submitted by jayabee52

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Once-Weekly Byetta Drug To Be Available In 2010

FDA review of Amylin Pharmaceuticals new once-weekly exenatide drug (called Byetta) is expected to be completed by March 5 of this year.

Submitted by Amy Tenderich

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Diabetes drug Byetta tied to kidney problems, says FDA

People with type 2 diabetes who are taking the blood-sugar-lowering drug Byetta may be at increased risk for kidney problems, including kidney failure, the U.S. Food and Drug Administration reported this week.

Submitted by Amy Tenderich

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New Report Released in North Carolina Shows Record Number of Medicines in Development to Treat Diabetes

The Pharmaceutical Research and Manufacturers of America (PhRMA) unveiled a new report today on medicines in the research pipeline for diabetes. The report shows that America's pharmaceutical research and biotechnology companies are testing a record 183 new diabetes medicines. The medicines listed in the report are being tested in human clinical trials or are awaiting approval by the U.S. Food and Drug Administration.

The report was released at a press conference in North Carolina featuring... read more

Submitted by Avera

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FDA approves generic diabetes treatment for Impax

HAYWARD, Calif. - Impax Laboratories Inc. said Tuesday federal regulators have approved the company's application to make generic versions of the diabetes treatment Precose.

The U.S. Food and Drug Administration approved an abbreviated new drug application for 25-, 50- and 100-milligram strengths of the tablets. Impax expects to launch all strengths in the fourth quarter.

Impax said in a statement U.S. generic and branded sales of the drug, also known as acarbose, in those three... read more

Submitted by Avera

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Under the radar

There's a new drug for type 2 diabetes, just approved by the FDA. Actually, it's an old drug, that has been approved for many years for other medical conditions, and which just got approval for treating diabetes.

I sort of stumbled across the news of its approval after a colleague sent out an e-mail (which indicated that he too was unaware of it until recently). With all the hullabaloo about several recent FDA reviews of... read more

Submitted by Avera

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FDA: Bristol-Myers diabetes drug appears safe

Federal health officials said Monday that a new potential blockbuster diabetes medication from Bristol-Myers Squibb -- called Onglyza -- appears free from heart-related side effects that have plagued similar treatments.

Onglyza is designed to reduce blood sugar levels in patients with type 2 diabetes.

Submitted by Amy Tenderich

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The Diabetes Community is Petitioning the FDA: Don’t Slam the Door on Progress!

I am submitting this as a news item by popular request so you all know about this important issue:

The FDA has made some moves that could potentially block progress in new diabetes treatments. They are quite out of touch with real patient needs, as well.

Please consider signing this petition calling for the creation of a real Diabetes Advisory Council:
www.healthefda.com

You can read about the background of this campaign on my site... read more

Submitted by Amy Tenderich

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FDA Roundup: Drugs for Depression, Diabetes and Psoriasis

In spite of that big broken water main, the FDA managed to make a bit of news before everything shuts down for the holiday. Three key items:

1. The agency isn’t ready to approve AstraZeneca’s drug Seroquel XR for major depressive disorder, the company said. The drug — an extended release version of the company’s blockbuster — has already been approved for bipolar disorder and schizophrenia.

But the agency issued a complete response letter... read more

Submitted by Avera

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