Approvals and designations made by the U.S. Food and Drug Administration for the week ended Feb. 2.
Approvals
* Allergan plc's Avycaz, for hospital-acquired infection bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug is already approved to treat complicated intra-abdominal and urinary tract infections. Pfizer Inc. is co-developing the drug, marketing it as Zavicefta in all regions except North America, where Allergan holds rights.
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| FDA headquarters in Silver Spring, Md. |
| Source: Associated Press |
Complete response letters
* Aradigm Corp.'s Linhaliq, for non-cystic fibrosis bronchiectasis. The FDA said it cannot approve the drug without independent verification for the company's late-stage trial results. The company plans to resubmit its new drug application for Linhaliq.
Fast track
* Protalix BioTherapeutics Inc.'s PRX-102, for Fabry disease. The company is evaluating the drug in three phase 3 trials.
* Takeda Pharmaceutical Co. Ltd.'s TAK-426, to immunize patients against the Zika virus. The vaccine is undergoing an early-stage trial in the U.S.
* Faron Pharmaceuticals Oy's Traumakine, for acute respiratory distress syndrome. The company is evaluating the drug in two late-stage trials.
Breakthrough therapy
* Roche Holding AG's balovaptan, for autism spectrum disorder.