FDAapproval72% confidence
List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (cardiology) as AstraZeneca.
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
- Cardiology · Heart Failure
- Sub-indication
- Hypertension
Related signal: AstraZeneca's Dapagliflozin Approved for Heart Failure; Real-World Study Launched in Germany