FDA Approvals, News & Updates
The FDA expanded its approval of subcutaneous tocilizumab (Actemra) for the treatment of adult patients with giant-cell arteritis, a chronic and severe autoimmune condition.
FDA Releases Draft Guidances on Sharing Healthcare Economic Information, Industry Communication Regulations
Two draft guidances released by the FDA in January 2017 explain the regulations in place for pharmaceutical manufacturers and decision-makers within the healthcare field (eg, payers, formulary committees) that share healthcare economic information (HCEI), and how communications should be handled in the industry with regard to drugs and devices that meet FDA labeling requirements, respectively.1,2
- Maci Approved for the Reparation of Cartilage Defects
FDA Approves First Tissue-Engineered Autologous Cellularized Scaffold Product for the Repair of Cartilage Defects
The FDA has approved Maci, the first tissue-engineered autologous cellularized scaffold product for the repair of symptomatic cartilage in adult patients with knee defects. Maci is composed of cells grown from the patient’s own healthy cartilage tissue, which are then placed onto a bioresorbable collagen membrane and surgically implanted over the area where the damaged tissue was removed.
- Abuse-Deterrent Troxyca ER Approved for Chronic Pain
On April 29, 2016, the FDA approved oxycodone (Xtampza ER) extended-release (ER) capsules, an opioid agonist, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- Adalimumab Biosimilar FDA-Approved to Treat Multiple Indications
- First Drug for Duchenne Muscular Dystrophy Granted Accelerated Approval
- FDA Approves Etanercept Biosimilar for Multiple Indications