Drug delivery company AptarGroup Inc (NYSE:ATR) reported on Thursday the receipt of US Food and Drug Administration (FDA) approval for its Unidose Powder System, an intranasal, needle-free rescue treatment drug intended to treat severe hypoglycemia in people with diabetes.
This is the first FDA approval of a prescription drug using Aptar's patented Unidose Powder System and is Aptar's first combination of a drug delivery device with a protective active packaging container.
According to the company, the Unidose Powder System is a single-use, ready-to-use one-step nasal delivery device which can deliver a powder formulation in an emergency situation quickly and easily. During such an event, the patient or caregiver presses a small plunger on the bottom of the device to release the drug in a single powder puff into the nose, where the drug can be quickly absorbed via the nasal mucosa.
The product is an alternative to injectable kits that may require assembly, including a multistep, time-consuming process of mixing powder and liquid.
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