Approvals and designations made by the U.S. Food and Drug Administration for the week ended March 9.
Approvals
* Roche Holding AG's cobas m 511, for identifying, counting and categorizing white blood cells, red blood cells and platelets. The company received 510(k) approval for the device.
* Abbott Laboratories' 15-millimeter Masters Series mechanical heart valves with Hemodynamic Plus sewing cuff, for newborn children with heart defects.
* Oxford Immunotec Global plc's Arrayed Fluorescent Immunoassay and Nucleic Acid Test, for detecting Babesia microti in human plasma samples and human whole blood samples, respectively. The company's unit Imugen Inc. received the approval.
* TaiMed Biologics Inc.'s Trogarzo, for HIV-1 in adult patients who cannot be treated using other therapies.
* Sunovion Pharmaceuticals Inc.'s Latuda, for major depressive episode associated with bipolar I disorder in children. The drug is already approved to treat certain patients with bipolar depression and schizophrenia. The company is an indirect unit of Sumitomo Dainippon Pharma Co. Ltd.
* 23andMe Inc.'s direct-to-consumer test, for identifying certain gene mutations linked with higher risk of breast, ovarian and prostate cancer.
* Amedica Corp.'s Valeo C+CsC, a composite spinal fusion implant. The spinal implant is already used in Europe.
* Quidel Corp.'s Sofia Lyme Fluorescent Immunoassay, for detecting certain antibodies to a bacteria that causes Lyme disease in serum or plasma samples. The company received 510(k) approval for the device.
* Corindus Vascular Robotics Inc.'s CorPath GRX platform, for robotic-assisted heart surgeries. The device was granted 510(k) approval. The platform is already approved for procedures related to artery diseases.
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| FDA headquarters in Silver Spring, Md. |
| Source: Associated Press |
Other designations
* Regenerative medicine advanced therapy, for MiMedx Group Inc.'s AmnioFix, to treat osteoarthritis of the knee.
* Orphan drug, for Protagonist Therapeutics Inc.'s PTG-300, to treat beta-thalassemia. The company plans to start global clinical trials for the injectable drug after its meetings with the U.S. and European regulatory agencies.
* Rare pediatric disease, for ProMetic Life Sciences Inc.'s inter-alpha-inhibitor-proteins, to treat necrotizing enterocolitis. The FDA granted an orphan drug designation to the drug in February.
* Orphan drug, for CSPC Pharmaceutical Group Ltd.'s DL-3-n-butylphthalide, to treat amyotrophic lateral sclerosis.

