27.04.2015 15:25:08
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MannKind To Manufacture 12 Unit Cartridge Strength Of AFREZZA Following FDA Nod
(RTTNews) - MannKind Corporation (MNKD) announced that it will begin to manufacture a 12 unit cartridge strength of AFREZZA (insulin human) Inhalation Powder to improve glycemic control in adult patients with diabetes.
The company stated that the 12 unit cartridge was approved by the U.S. Food and Drug Administration on April 17, 2015 and is expected to be launched by Sanofi in the second half of 2015.
The new dosage strength complements the existing 4 unit and 8 unit cartridges and will provide patients with another option to receive their prescribed dose.
Commenting on Afrezza (insulin human) Inhalation Powder, the company said it is used to control high blood sugar in adults with type 1 and type 2 diabetes. The drug-device combination product consists of a dry formulation of human insulin delivered in a specially designed inhaler. Administered at the beginning of a meal, Afrezza delivers insulin into the body through the lungs with peak insulin levels achieved within 12 to 15 minutes.
Sanofi and MannKind have entered into a worldwide exclusive licensing agreement to develop and commercialize Afrezza. Under the collaboration agreement, Sanofi is responsible for global commercial, regulatory and development activities.
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