FDA Says FENOGLIDE Was Not Withdrawn for Safety or Effectiveness Reasons
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA determined that FENOGLIDE (fenofibrate) 40 mg and 120 mg was not withdrawn from sale because of safety or effectiveness concerns. That matters for generic drug makers: FDA will not start the process of removing pending generic applications that rely on this drug, and it can keep approving new ones if they meet the usual requirements. For Salix Pharmaceuticals and companies developing fenofibrate generics, this keeps the product on FDA’s discontinued drug list but preserves the path for ANDA approvals. Businesses should treat this as a green light for continued generic review, while watching for any future labeling changes FDA may require.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- FDA determined FENOGLIDE was not withdrawn from sale for safety or effectiveness reasons.
- FDA will not start procedures to withdraw ANDA approvals that reference FENOGLIDE.
- New ANDAs for FENOGLIDE may still be approved if they meet legal and regulatory requirements.
Obligations
What this law requires
FDA will continue to list FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg, in the Orange Book's Discontinued Drug Product List because it was determined not to have been withdrawn from sale for reasons of safety or effectiveness.
FDA must continue listing FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg, in the Orange Book's Discontinued Drug Product List because it was determined not to have been withdrawn for reasons of safety or effectiveness.
FDA must continue listing FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg, in the Orange Book's Discontinued Drug Product List because it determined the product was not withdrawn from sale for reasons of safety or effectiveness.
FDA must not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg, based solely on the product's discontinuation status.
FDA must not begin procedures to withdraw approval of any abbreviated new drug application (ANDA) that refers to FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg, on the basis that the product was withdrawn from sale for safety or effectiveness reasons.