Breakthrough Therapy for Depression Approved by FDA

| By | FDA Approved

Aptar Pharma, a leading drug delivery systems provider, is pleased to announce that its Bidose nasal spray device was recently approved by the U.S. FDA for a breakthrough therapy in the field of depression. This marks the first FDA approval and U.S. launch of a prescription drug using Aptar Pharma’s patented Bidose nasal spray delivery system.

This approval again demonstrates Aptar Pharma’s expertise in developing patient-friendly drug delivery solutions for breakthrough medicines. Aptar Pharma offers a broad portfolio of innovative technologies and a wide array of services to meet the highest quality standards of the pharmaceutical industry.

Designed for local or systemic delivery of drugs, Aptar Pharma’s Bidose liquid system is a robust, primeless, intuitive and easy-to-use device with 360° functionality and precise spray characteristics and provides accurate two-shot nasal drug delivery.

This customized Bidose liquid device is produced in Aptar Pharma’s state-of-the-art manufacturing facility in Congers, NY, which offers laboratory and other organizational capabilities to support nasal and injectable drug delivery systems.

This breakthrough therapy approval is an example of a Combination Product, and benefited from Aptar Pharma’s Services offering, a comprehensive portfolio of stage-specific packages designed to proactively address regulatory needs to accelerate approval.

We are pleased that Aptar Pharma’s Bidose nasal delivery device has been approved by the FDA for this breakthrough therapy in the field of depression. This project marks close to a 10-year customer collaboration and once again demonstrates Aptar Pharma’s ability to develop and launch complex drug delivery systems worldwide,

explained Gael Touya, President, Aptar Pharma.

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