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FDA Watch: Approvals for Astellas, Salix; designations for Roche, Sellas

Approvals and designations made by the U.S. Food and Drug Administration for the week ended May 11.


* Astellas Pharma Inc.'s Myrbetriq-Vesicare combo, to treat overactive bladder. The drugs are already approved as monotherapies for treating overactive bladder.

* Salix Pharmaceuticals Ltd.'s Plenvu, a bowel preparation therapy for patients who will undergo colon cancer screening. The company is a unit of Valeant Pharmaceuticals International Inc.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Complete response letters

* Lipocine Inc.'s Tlando, a potential testosterone replacement therapy for adult male patients with hypogonadism — diminished functional activity of the gonads. The FDA rejected the application due to insufficient and unreliable data.

Priority review

* Roche Holding AG's Tecentriq combo, as a first-line treatment for non-squamous, non-small cell lung cancer that has spread to other parts of the body. The application, which has a Sept. 5 target action date, covers treatment comprising Tecentriq, Avastin and chemotherapy.

Other designations: orphan drug

* Sellas Life Sciences Group Inc.'s galinpepimut-S, for multiple myeloma.

* Cellectar Biosciences Inc.'s CLR 131, for rhabdomyosarcoma. The FDA previously granted CLR 131 rare pediatric disease status to treat neuroblastoma.