FDA News Briefs for Monday, June 3, 2019June 3, 2019
These Food and Drug Administration (FDA) developments came in last week:
FDA Expands Approval for Lyrica
The FDA has granted expanded approval for Lyrica (pregabalin; Pfizer) as an adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Lyrica was previously approved as an adjunctive therapy for adult patients with partial onset seizure, as well as for treatment of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, and neuropathic pain associated with spinal cord injury. More Information.
FDA Recall: Solopath Systems
Terumo Medical Corporation has issued a recall for the Solopath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to potential tip dislodgement. Use of this product could cause vessel dissection, false lumen, pseudoaneurysm, hemorrhage, vessel perforation, and vessel disruption. The FDA identified this as a Class I recall, as use of the product may result in subsequent interventions, increased procedure times, or death. More Information.