Showing posts with label fda. Show all posts
Showing posts with label fda. 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.
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
FDA Considers OTC Version of the Fat blocker Xenical
Sunday, April 13, 2014
Xenical® may become the first government-approved weight-loss drug available without a prescription.
In 1999, Roche Laboratories, Inc. received marketing approval for orlistat (brand name: Xenical®) and has sold it as a prescription drug since. This afternoon, an FDA advisory panel is considering making a lower-dose version (60 mg. capsules, prescription strength is 120 mg. capsules) available for sale over-the-counter (OTC), without a prescription.
Xenical works locally in the digestive tract to block absorption of about 25% to 30% of the fat in a meal. One of the FDAs concerns is that the drug would also block absorption of fat-soluble vitamins E, D, K, and beta-carotene.
The FDA lists the most common side effects of orlistat as:
If approved, GSK will market the 60 mg. OTC version of orlistat as "Alli", pronounced ally - a erence to its use as an ally or helper in a total weight-loss program.
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For an FDA Fact Sheet on Xenical (open as a pdf file):
Xenical (orlistat)
For some news summaries:
FDA Mulling OTC Sale of Fat Blocking Pill
FDA Finds Risk in GlaxoSmithKline PLCs Xenical Diet Pill
In 1999, Roche Laboratories, Inc. received marketing approval for orlistat (brand name: Xenical®) and has sold it as a prescription drug since. This afternoon, an FDA advisory panel is considering making a lower-dose version (60 mg. capsules, prescription strength is 120 mg. capsules) available for sale over-the-counter (OTC), without a prescription.
Xenical works locally in the digestive tract to block absorption of about 25% to 30% of the fat in a meal. One of the FDAs concerns is that the drug would also block absorption of fat-soluble vitamins E, D, K, and beta-carotene.
The FDA lists the most common side effects of orlistat as:
- Oily spotting
- Gas with discharge
- Fecal urgency
- Fatty/oily stools
- Frequent bowel movements
If approved, GSK will market the 60 mg. OTC version of orlistat as "Alli", pronounced ally - a erence to its use as an ally or helper in a total weight-loss program.
For an FDA Fact Sheet on Xenical (open as a pdf file):
Xenical (orlistat)
For some news summaries:
FDA Mulling OTC Sale of Fat Blocking Pill
FDA Finds Risk in GlaxoSmithKline PLCs Xenical Diet Pill
FDA Video On Diabetes Devices
Saturday, March 1, 2014
A quick little video by the FDA on the devices used to check blood glucose and inject insulin:
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