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Approvals for Sarepta Therapeutics, Amarin; designations for Dermira, CSL


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Approvals for Sarepta Therapeutics, Amarin; designations for Dermira, CSL

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 13.


* Sarepta Therapeutics Inc.'s Vyondys 53 injection for Duchenne muscular dystrophy, or DMD. The drug was granted accelerated approval after an initial rejection by the U.S. regulator in August.

* Amarin Corp. PLC's Vascepa to reduce risk of cardiovascular events in patients with triglyceride levels of 150 milligrams per deciliter or higher, who also have established cardiovascular disease or diabetes plus at least two other cardiovascular risk factors.

* PerkinElmer Inc.'s GSP Neonatal Creatine Kinase-MM kit to test for DMD in newborns.

* Tandem Diabetes Care Inc.'s Control-IQ Technology for automated insulin delivery, which allows automatic adjustments of the insulin dose based on blood glucose readings and a history of insulin delivery.

* Cochlear Ltd.'s Osia 2 System ear implant that uses wireless technology.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: AP Photo

Fast track

* Dermira Inc.'s lebrikizumab for atopic dermatitis.

* Equillium Inc.'s itolizumab for kidney inflammation in lupus patients.

* VistaGen Therapeutics Inc.'s nasal spray PH94B for social anxiety disorder.

Other designations

* Orphan drug, for CSL Ltd.'s Hizentra as a maintenance therapy to prevent the return of chronic inflammatory demyelinating polyneuropathy in certain adult patients.

* Rare pediatric disease designation, for Y-mAbs Therapeutics Inc.'s GD2-GD3 Vaccine for children with neuroblastoma.