Showing posts with label approval. Show all posts
Showing posts with label approval. Show all posts

Mercks Januvia™ Receives FDA Approval

Tuesday, April 15, 2014


On October 17, 2006, the FDA approved Mercks Januvia™ for type 2 diabetes.

Januvia (sitagliptin) is an incretin enhancer. For a brief primer on how these drugs work, visit our post:
New Diabetes Drugs on the Horizon: Incretin Enhancers

Merck states the recommended dose as 100 mg/day. The 100 mg tablets will be available in pharmacies in the near future. Price: $4.86/tablet.

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For FDAs press release:
FDA Approves New Treatment for Diabetes

For Mercks press release:
FDA Approves Once-Daily JANUVIA™, the First and Only DPP-4 Inhibitor Available in the United States for Type 2 Diabetes

For Januvias site:
Januvia
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Medtronics Insulin Pump with Glucose Monitor Gets FDA Approval

Saturday, February 1, 2014


In a healthy person, the body senses insulin need and dispenses the hormone without the persons conscious thought or action. Future technologies may one day be able to mimic this unconscious sensing and dispensing of insulin for people with diabetes.

Last week, medical science moved a step closer to such a "closed loop" system with the FDAs approval of Medtronics insulin pump and glucose monitoring system.

The MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System sends glucose readings every 5 minutes from a sensor to the pump. These continuous readings allow a user to monitor their glucose throughout the day. The system includes an alarm that vibrates or sounds when blood glucose is too high or too low, especially useful when sleeping. Action can be taken to improve glucose levels after a fingerstick confirmation.

MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System"Integrating an insulin pump with REAL-Time CGM is a major step toward the development of a “closed-loop” insulin delivery system that may one day mimic some functions of the human pancreas."
- Medtronics press release

MiniMeds REAL-Time System is shown at right:
A - Insulin pump
B - Insulin delivery
C - Glucose sensor
D - Transmitter

If youre interested in just continuous glucose monitoring (CGM) without a pump, MiniMed currently sells the Guardian® RT CGM System.

Or you can buy the MiniMed Paradigm 522/722 insulin pump and use it without the glucose monitoring system. Later, if you decide to try continuous monitoring, you can purchase the REAL-Time Continuous Glucose Monitoring Kit, designed to be used with those pumps. The monitoring kit should be available this summer.

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For Medtronics press release:
Medtronic Receives FDA Approval for Worlds First Insulin Pump with Real-Time Continuous Glucose Monitoring
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