Fabrazyme full approval?

Yes. Fabrazyme (agalsidase beta) has full FDA approval for the treatment of Fabry disease in patients with a confirmed diagnosis. It received standard (full) approval in 2003.

Notes:
- It’s an enzyme replacement therapy used to replace the deficient enzyme in Fabry disease.
- It’s approved for adults and pediatric patients with confirmed Fabry disease (age ranges are in the label; check current labeling for exact details).
- There is another enzyme replacement therapy, Replagal (agalsidase alfa), approved in the EU, but it’s not the same product as Fabrazyme.

If you want, I can pull up the current labeling details (indications, age range, dosing) or compare Fabrazyme to Replagal.