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FDA Watch: Approval for Johnson & Johnson; designations for Neovasc, Iovance

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Oct. 12.

Approvals

* 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.

SNL Image
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.

Breakthrough therapy

* Neovasc Inc.'s Reducer chest pain device, for patients with refractory angina.

Other designations

* 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.