Biotech Values

[DewDiligence]

It's not the FDA that differentiates, it's the sponsor. They intentionally file as a brand as a business strategy.

It’s not always the sponsor’s intent to have a non-substitutable product. Duramed’s Cenestin, which was the subject of a recent thread on this board, is a case in point. The FDA rejected the ANDA and told Duramed to resubmit under 505b2.