Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

And Complete as of 7/20/17.

From a previous post

they are giving a high dose 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day -2 whereas the approved label gives 200 mg/m2 of Evomela over 2 days (100 mg/m2 per day). Giving a high dose of 200 mg/m2 of Melphalan HCl for injection as a one-time infusion is how the generic is given to patients.

I assume/wondering if they can get a revised label (via sBLA) to include both dosing methods?