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FDA Watch: Approval for Allergan; designations for Roche, Protalix

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.

SNL Image
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.