FDAapproval84% confidence
List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to Micro Labs; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an ANDA referencing that NDA drug product.
Supporting Context
- Therapeutic area
- Cardiovascular · Anticoagulant
- Sub-indication
- General
Related signal: FDA Grants Approval for Rivaroxaban Generic by Micro Labs