Tag Archives: CRL

June, 2018

  • 18 June

    FDA Fails to Approve Valeant’s Plaque Psoriasis Treatment

    LAVAL, Quebec, June 18, 2018 /PRNewswire/ — Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) for DUOBRII™1 (halobetasol propionate and tazarotene) …

May, 2018

April, 2018

July, 2017

June, 2017

January, 2017

  • 13 January

    FDA Denies Approval of Tesaro’s NDA for its Rolapitant IV

    WALTHAM, Mass., Jan. 11, 2017 (GLOBE NEWSWIRE) — TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the rolapitant IV New Drug Application (NDA) for the prevention of delayed nausea and vomiting associated with …

October, 2016

October, 2015

  • 23 October

    FDA Declines to Approve Spectrum’s Blood Cancer Drug

    HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA). A Complete Response Letter is a communication …