Approvals and designations made by the U.S. Food and Drug Administration for the week ended Oct. 12.
* Johnson & Johnson's Xarelto, in combination with aspirin, to treat patients with coronary artery disease or peripheral arterial disease.
* Grifols SA's ID CORE XT, a test to determine blood compatibility for transfusions.
* Akorn Inc.'s bimatoprost ophthalmic solution, for hypotrichosis.
* Bausch Health Cos. Inc.'s Bryhali lotion, for adults with plaque psoriasis. The FDA granted tentative approval to Bausch Health.
|FDA headquarters in Silver Spring, Md.|
|Source: Associated Press|
Complete response letters
* TearLab Corp.'s TearLab Discovery MMP-9 test, which helps diagnose dry eye disease. The FDA said the data in TearLab's regulatory submission has not met the criteria for substantial equivalence.
* Neovasc Inc.'s Reducer chest pain device, for patients with refractory angina.
* Regenerative medicine advanced therapy, for Iovance Biotherapeutics Inc.'s lifileucel, to treat advanced melanoma.
* Orphan drug, for Sutro Biopharma Inc.'s STRO-001, to treat multiple myeloma.
* Qualified infectious disease product, for Spero Therapeutics Inc.'s SPR206, to treat urinary tract infections, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.