Approvals and designations made by the U.S. Food and Drug Administration for the week ended Aug. 9.
Complete response letters
* Kala Pharmaceuticals Inc.'s KPI-121 0.25% therapy to treat symptoms of dry eye disease.
* Intra-Cellular Therapies Inc.'s lumateperone for schizophrenia. The FDA classified the New York-based company's planned submission of additional information as a major amendment to its application.
* Avadel Pharmaceuticals PLC's injectable hospital product candidate AV001 for an undisclosed indication. Dublin-based Avadel said it submitted additional information requested by the FDA which was considered by the regulator as a major amendment to the company's application.
FDA headquarters in Silver Spring, Md.
* Alnylam Pharmaceuticals Inc.'s givosiran for acute hepatic porphyria. The FDA said efficacy data from an additional clinical trial will be needed to support resubmission of the application.
* Provention Bio Inc.'s PRV-031 for preventing and delaying type 1 diabetes.