Iconovo receives positive guidance from FDA regarding substitutability for ICOpre

Iconovo announces that the US Food and Drug Administration (FDA) has issued a positive guidance regarding the generic substitutability of the company’s proprietary inhaler ICOpre® with the original drug Breo Ellipta with respect to external design and operating principles.

The FDA’s preliminary view is that ICOpre with its current external design attributes and operating principle is appropriate for submission in an Abbreviated New Drug Application (ANDA) for a generic Breo product. In addition, the FDA provides guidance regarding the configuration of the final ANDA to be able to provide substitutability.

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