FDA Approved Indications for this Orphan Drug:

For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emphysema.

FDA Marketing Approval issued as of:

Orphan Drug exclusivity ends on:
Company Making and Marketing this drug:
Bayer Corporation

FDA Designation Date:

FDA Drug Designation:
For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state.