Keeping Track: Amgen Parsabiv Is Latest To Receive Complete Response; Pfizer Troxyca ER Finally Approved; Remune Returns
The latest drug development news and highlights from our FDA Performance Tracker.
You may also be interested in...
FDA approved Pfizer’s oxycodone/naltrexone extended release opioid with abuse deterrent claims similar to Embeda. That isn’t the label FDA’s advisory committee supported.
But Amgen is in good company when it comes to companies that choose not to disclose the contents of complete response letters, data from the Pink Sheet's FDA Performance Tracker show. Merck especially holds such information close.
FDA issued a complete response letter for the Sensipar follow-on, and Amgen declined to provide any details about the reason why or timeline for resubmission.