Question on ANDA definition [Regulatives / Guidelines]

posted by jag009  – NJ, 2012-07-13 18:23 (5099 d 22:16 ago) – Posting: # 8946
Views: 4,065

Hi,

A stupid question on my part but it's friday :party:

The innovator drug is a capsule containing two population of beads (IR beads and ER beads). Another company develops a drug which is bioequivalent to the innovator (Cmax and AUCs). The product is also a capsule but it contains a single population of beads with IR coating on top of ER Core.

Is this considered an ANDA filing?

Thanks

John

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