Biotech Values

[DewDiligence]

What was FDA's rationale for the delay for omnitrope which required NVS to sue for approval.

The FDA claimed it didn’t have the regulatory authority to approve a knockoff of a protein drug (PFE’s Genotropin) based on a 505b2 NDA that lacked a full dossier of clinical data. The federal court told the FDA that it did.

Lovenox and Copaxone are not protein drugs and NVS/MNTA’s applications are not NDA’s, so the Omnitrope case is not directly applicable to either of them.