Sanofi and MannKind Corporation have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin
Tag: Afrezza
Will I prescribe Afrezza for people with diabetes? Not a lot, and not for past or present smokers, and not for people with any breathing problems (or heart issues that might cause difficulty breathing), and not without getting pulmonary function testing and explaining all of what I see as potential risks, and not without close follow-up.
The U.S. FDA approved Mannkind Corporation's Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin, to improve glycemic control in adults with diabetes mellitus. Afrezza is administered at the beginning of each meal, or within 20 minutes after starting a meal.
The U.S. FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 1 to recommend that Afrezza (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA
MannKind Corporation has resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AFREZZA (insulin human [rDNA origin]) Inhalation Powder with an indication to improve glycemic control in adults with type 1 or type 2 diabetes.
MannKind Corporation has announced that it has positive preliminary results from two Phase 3 clinical studies of Afrezza, inhaled ultra rapid-acting mealtime insulin.
MannKind Corporation announced that it has confirmed with the U.S. Food and Drug Administration the design of two clinical studies that evaluate the efficacy and safety of AFREZZA (insulin human [rDNA origin]), an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind's next-generation inhaler...
Treating type 1 and type 2 diabetes with investigational ultra rapid acting mealtime insulin Afrezza (insulin human [rDNA origin]) Inhalation Powder does not result in excess cardiovascular events according to two new studies being presented at the American Diabetes Association's...
The FDA's Center for Drug Evaluation and Research has issued a complete response letter to Mannkind corp. regarding the New Drug Application (NDA) for Afrezza (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes...
The FDA informed MannKind Corporation that it would not be able to complete the review of the New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) Inhalation Powder by the action date of December 29, 2010. The FDA stated that it will require approximately four additional weeks to complete its review of the NDA...