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Approvals for Roche, J&J; designations for AstraZeneca, ProQR Therapeutics


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Approvals for Roche, J&J; designations for AstraZeneca, ProQR Therapeutics

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Oct. 18.


* Roche Holding AG's Xofluza for people at high risk of developing complications from influenza. Xofluza was previously approved to treat acute, uncomplicated influenza in people aged 12 years and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications.

* Johnson & Johnson and Bayer AG's Xarelto to prevent venous thromboembolism in acutely ill patients who are at risk of developing blood clot complications but are not at a high risk of bleeding.

* Amgen Inc.'s Nplate for newly diagnosed adults with immune thrombocytopenia, or ITP, and who have had an insufficient response to corticosteroids, immunoglobulins or surgery to remove the spleen. Nplate is already approved to treat ITP in adults and children aged one year and older.

* Hisamitsu Pharmaceutical Co. Inc. unit Noven Pharmaceuticals Inc.'s Secuado over-the-skin patch for adults with schizophrenia.

* Alkermes PLC and Biogen Inc.'s Vumerity for multiple sclerosis. The FDA granted tentative approval to the companies' application.

* Foamix Pharmaceuticals Ltd.'s Amzeeq for moderate to severe acne in patients aged nine years and older.

Extended review

* Flexion Therapeutics Inc.'s supplemental new drug application to revise the label of its osteoarthritis knee pain drug Zilretta. The Burlington, Mass.-based company said the FDA did not ask for new information.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: AP Photo

Priority review

* AstraZeneca PLC and Daiichi Sankyo Co. Ltd.'s trastuzumab deruxtecan for breast cancer which has spread across the body and is human epidermal growth factor receptor 2-positive.

Other designations

* Rare pediatric disease designation, for ProQR Therapeutics NV's sepofarsen for Leber's congenital amaurosis 10.

* Orphan drug, for Neuren Pharmaceuticals Ltd.'s NNZ-2591 for Angelman syndrome, Phelan-McDermid syndrome and Pitt Hopkins syndrome.