Alerts

FDA Wants More Info on New Pen Delivery for Amylin’s Bydureon Amylin said it will comply with the FDA’s request for “incremental device-related data” and hopes to have the pen-delivery formulation of Bydureon on the market by 2013. 

Janssen Submits NDA for Canagliflozin  Janssen Research & Development, LLC has submitted a New Drug Application (NDA) to the FDA seeking approval for the use of canagliflozin, an investigational, oral, once-daily, selective sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes.

FDA Approves Two Generics of Clopidogrel (Plavix) The US Food and Drug Administration (FDA) has approved 2 generic versions of the ubiquitous anticoagulant clopidogrel (Plavix, Bristol-Meyers Squibb/Sanofi). It is one of the best-selling drugs indicated for patients who have had a recent heart attack or stroke or who have peripheral …

FDA Panel Gives Nod to New Diet Drug An FDA advisory committee has voted 18-4, with one abstention, in favor of approving lorcaserin hydrochloride (Lorqess). It would be the first new weight loss drug in more than a decade.   

Fast-Acting Erectile Dysfunction Drug Stendra (TM) (avanafil) Approved

ADA/EASD Issue New Management Guidelines (see this week’s Item #2) and FDA Rejects Diabetes Drug Alogliptin (see this week’s Item #10).

FDA pushes back decision on weight loss drug Qnexa to July 17. 

FDA Okays Levemir for Pregnant Women  The FDA had approved Levemir (insulin detemir [rDNA origin]) for a pregnancy category B classification, meaning that when used by pregnant women, the insulin did not increase the risk of harm to fetuses. The agency’s decision was based on results of a clinical trial …

Johnson & Johnson to possibly sell their Animas Diabetes Pump and One Touch Glucose Monitor divisions.  

Amylin rejects Bristol-Myers Squibb’s 3.5 billion purchase offer.