Cerezyme fda approval date?

When did the FDA approve Cerezyme?

Cerezyme (imiglucerase) received FDA approval on April 7, 1994 [1].

What is Cerezyme used for?

Cerezyme is an enzyme replacement therapy indicated for the treatment of non-neuronopathic (Type 1) Gaucher disease and later expanded indications for neuronopathic Gaucher disease (Type 2 and Type 3) depending on patient category and clinician use [1].

What does the approval date mean for patients and coverage?

The FDA approval date is the point when the product first received authorization to be marketed in the U.S. for its initial indication. Policies for insurance coverage and treatment eligibility are set separately by payers and clinicians, but the approval date is often referenced in regulatory and reimbursement contexts [1].

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020224