Aptar wins FDA approval for Unidose Powder System for nasal spray of hypoglycemia drug
AptarGroup (Aptar) said that its Unidose Powder System has been approved by the US Food and Drug Administration (FDA) for the intranasal, needle-free rescue treatment drug – Lilly’s Baqsimi nasal powder, which was indicated for the treatment of severe hypoglycemia in people with diabetes. (Read Baqsimi FDA approval)
The announcement marks the first approval by the FDA of a prescription drug using Aptar’s Unidose Powder System. It is also the first combination of a drug delivery device with a protective active packaging container for Aptar.
Gael Touya – President of Aptar Pharma said: “We are pleased to announce that Aptar Pharma’s Unidose Powder System has been approved by the FDA for the first intranasally-delivered, needle-free rescue treatment for severe hypoglycemia that provides a more patient-friendly delivery approach. Our active packaging container helps to protect the device and better ensure its quality until the moment of use.
“This project marks a nearly 10-year customer collaboration and once again demonstrates Aptar Pharma’s ability to help our customers develop and launch complex treatments with patient-friendly delivery systems worldwide.”
The Unidose Powder System is a single-use, ready-to-use one-step nasal delivery device, designed to provide a powder formulation in an emergency situation quickly and easily. Patient or caregiver has to press a small plunger on the bottom of the Unidose Powder System to release the drug in a single powder puff into the nose, enabling it to be absorbed quickly through the nasal mucosa.
Stephan Tanda – President and CEO of Aptar said: “This successful approval confirms the value that we are bringing to our customers in the highly competitive pharmaceutical and biotech industries. With decades of experience in the long-term testing and development phases that are required by regulatory agencies, we are building a stronger solutions platform for the future, and this launch is a glimpse of that future.
“Our lab and analytic service capabilities combined with our unique drug delivery devices and active packaging solutions create tremendous value for our customers and help them secure approval. The ultimate end result is that we help expand access to life-saving treatments with our patient-friendly systems.”
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