The 505(b)(2) new drug application: expediting the pathway to market for inhalation products

Inhaled products represent one of the most effective strategies to deliver therapeutic concentrations directly to the site of treatment.

Inhaled therapeutics offer drug developers many advantages, such as improved performance and increased shelf-life for existing drug products. Additionally, the 505(b)(2) New Drug Application (NDA) introduced by the US Food and Drug Administration (FDA) provides an efficient pathway to market for new inhalation formulations using well understood active pharmaceutical ingredients (APIs). 

Aditya R. Das, PhD., MBA, director of business development, at Recipharm discusses how the 505(b)(2) NDA allows inhalation products to efficiently progress to market. He also explores the key benefits of inhalation medicines and the use of respirable engineered spray dried powder in product development.

For the full article see pg 44-47 here:
https://www.pharmanetwork.digital/html5/reader/production/default.aspx?pubname=&pubid=4d995046-b0c9-4bf7-8936-56d1e96cf9d7

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