Approvals and designations made by the U.S. Food and Drug Administration for the week ended Feb. 23.
Approvals
* KemPharm Inc.'s Apadaz, for the short-term management of acute pain severe enough to require an opioid drug and for which alternative treatments are not adequate.
* Corindus Vascular Robotics Inc.'s CorPath GRX system, for artery surgeries on limbs. The device was already granted 510(k) clearance for coronary artery disease.
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| FDA headquarters in Silver Spring, Md. |
| Source: Associated Press |
Complete response letters
* PTC Therapeutics Inc.'s ataluren, for Duchenne muscular dystrophy. The FDA already rejected the drug in October 2017 due to inconclusive data.
Priority review
* Shire plc's lanadelumab, for hereditary angioedema. The application's target action date is Aug. 26.
Other designations: orphan drug
* Kazia Therapeutics Ltd.'s GDC-0084, for glioblastoma multiforme. The company licensed the drug from Roche Holding AG's Genentech Inc.
* ContraVir Pharmaceuticals Inc.'s tenofovir exalidex, for children with hepatitis B.