Category Archives: Fda

FDA Approves Two-In-One Diabetes Treatment For Type 2

By Brenda Neugent The U.S. Food and Drug Administration recently approved a two-in-one diabetes treatment that combines two type 2 treatments. Glyxambi combines empagliflozin, a sodium glucose cotransporter-2 inhibitor that blocks the absorption of excess glucose by the kidneys so it is released through urine, and linagliptin, a DPP-4 inhibitor that increases the production of … Continue reading FDA Approves Two-In-One Diabetes Treatment For Type 2

Insulin Pens are Not for Sharing: Diabetes Health Editor’s Note

The FDA reminds us why sharing insulin pens may create long terms health concerns. While some people do save on costs when reusing and or sharing insulin pens, the possible long term complications are not worth the savings. By Food and Drug Administration The Food and Drug Administration (FDA) is reminding health care professionals and … Continue reading Insulin Pens are Not for Sharing: Diabetes Health Editor’s Note

FDA Approves Two-In-One Diabetes Treatment

The U.S. Food and Drug Administration has approved a new drug from AstraZeneca that combines two drugs in one to help lower blood glucose in those with  . The new drug, Xigduo XR, is a once-daily tablet that merges the recently approved diabetes drug dapagliflozin with the popular drug metformin. Dapagliflozin, a product of AstraZeneca … Continue reading FDA Approves Two-In-One Diabetes Treatment

FDA Approves Once-weekly Trulicity to Treat Type 2 Diabetes

The U.S. Food and Drug Administration recently approved Trulicity, a once-weekly injectable to treat adults with type 2 diabetes. Also known as dulaglutide, Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, which helps normalize blood sugar levels by encouraging the release of insulin, which helps the body better use available blood glucose, while suppressing the … Continue reading FDA Approves Once-weekly Trulicity to Treat Type 2 Diabetes

FDA Delays Decision on Inhaled Insulin

The Food and Drug Administration (FDA) has delayed until July 15th making a decision on whether to allow the inhaled insulin Afrezza entry into the American market. Manufactured by Valencia, Calif.-based MannKind Corp., Afrezza uses a small inhaler that delivers insulin powder into the lungs. It is aimed at both type 1 and type 2 … Continue reading FDA Delays Decision on Inhaled Insulin

Prodigy Diabetes Care Moves Forward After FDA Concludes Regulatory Action

CHARLOTTE, N.C., April 16, 2014 /PRNewswire/ — On April 10, 2014 the U.S. Food & Drug Administration (FDA) issued a “Closeout” letter to Prodigy Diabetes Care to formally conclude the regulatory action that resulted in a Warning Letter on February 22, 2013. Since the original site inspection of Prodigy in March 2012, and in response to … Continue reading Prodigy Diabetes Care Moves Forward After FDA Concludes Regulatory Action

Inhaled Insulin to Treat Diabetes Earns FDA Committee Recommendation

The inhaled insulin Afrezza has been recommended for approval by a Food and Drug Administration (FDA) advisory committee. The drug, an inhaled powder, completed phase III testing in August of 2013. If approved, it will be the first ultra rapid-acting mealtime insulin therapy available in the United States. The advisory committee recommended that the drug … Continue reading Inhaled Insulin to Treat Diabetes Earns FDA Committee Recommendation