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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-84/
- Published: 2019-02-24T12:00:00.000Z
- Updated: 2026-09-15T01:07:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137089

**BIOLOGICS**

FDA has approved a Protein Sciences BLA for its quadrivalent formulation of [Flublokinfluenza vaccine](http://www.flublok.com/?ref=fdaweb.com), which protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. Approval was based on data from a clinical study of 9,000 adults 50 years of age and older, which showed that those who received Flublok Quadrivalent were over 40% less likely to get cell-culture confirmed influenza than those that received a leading egg-produced quadrivalent flu vaccine.

**DEVICES**

FDA has approved a **Medtronic** PMA for its cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla magnetic resonance imaging (MRI) machines. The approval covers the company’s SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators and leads for MRI scans on any part of the body.

FDA has approved a St. Jude Medical PMA for the Infinity Deep Brain Stimulation (DBS) system and its DBS directional leads, which the company describes as the first directional lead approved in the U.S. The device is intended to treat two of the most common movement disorders — Parkinson’s disease and essential tremor.

**DRUGS**

FDA has approved Lundbeck’s Carnexiv (carbamazepine) injection as a short-term replacement therapy for an oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received an orphan drug designation for this indication and will be the first available intravenous formulation of the antiepileptic drug.