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) …
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3 May
Sandoz Receives Complete Response Letter from the FDA for Proposed Biosimilar Rituximab

Holzkirchen, May 2, 2018 – Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab. Sandoz stands behind the robust body of evidence included in the regulatory submission and …
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23 April
FDA Requests Additional Information for Pfizer’s Application for its Proposed Trastuzumab Biosimilar

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that it received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, the FDA highlighted the need for additional technical information. The …
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17 July
FDA Rejects Amgen’s Romosozumab for Treatment of Postmenopausal Women with Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, July 16, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY™* (romosozumab) as a treatment for postmenopausal women with osteoporosis. The original submission included data from the pivotal …
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23 June
FDA Rejects Pfizer’s BLA for Proposed Epoetin Alfa Biosimilar

NEW YORK, N.Y., June 22 – Pfizer Inc. (NYSE:PFE) today announced that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for its proposed epoetin alfa biosimilar. This CRL relates to matters noted in …
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12 June
FDA Rejects Coherus’ Application for Proposed Biosimilar to Amgen’s Neulasta

REDWOOD CITY, Calif., June 12, 2017 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for its biologics license application (“BLA”) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, under the 351(k) pathway. The CRL primarily …
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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 …
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31 October
FDA Rejects Sanofi and Regeneron’s Rheumatoid Arthritis Drug due to Manufacturing Concerns

Paris and Tarrytown, N.Y. – October 28, 2016 – Sanofi and Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with …
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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 …
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