Pharmaceutical Product Guide » Sanofi-Aventis

FDA approval to Apidra(R) for diabetic children

Kimberly O'Brien — Fri, 31 Oct 2008 06:21:01 +0000

The U.S. Food and Drug Administration has approved Sanofi-aventis’ Apidra (insulin glulisine injection) to recover glycemic control in children above the age of 4 years suffering from diabetes mellitus. The approval for pediatric use of the injection is based upon FDA’s review of a 6 month long phase III study involving 572 children with type 1 diabetes. Apidra(R), having a rapid onset and shorter period of action, should normally be used along with a basal insulin with a longer duration of action. The product can also be applied in insulin infusion pump treatment for controlling blood sugar.

Kimberly O'Brien — Wed, 01 Oct 2008 07:58:06 +0000

The U.S. Food and Drug Administration (FDA) has approved Sanofi-aventis’ Nasacort AQ Nasal Spray for children aged 2-5 years old. The spray (triamcinolone acetonide) treats nasal symptoms associated with allergic rhinitis.The approval was given on the basis of the results of a placebo- controlled trial that found it to be safe and effective.

Positive appraisal for Acomplia from NICE

Kimberly O'Brien — Mon, 07 Apr 2008 23:55:29 +0000

Acomplia, the obesity drug manufactured by Sanofi-Aventis, has received a positive final appraisal determination from the National Institute for Health and Clinical Excellence (NICE) in the U.K. The body has also guided to the use of Acomplia as a support for diet and exercise in overweight patients who have not responded to other obesity agents.