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FDA Watch: Approvals for KemPharm, Corindus; designations for Shire, Kazia

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Feb. 23.


* 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.

SNL Image
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.