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  • 761102Orig1s000 - Food and Drug Administration
    BLA Multidisciplinary Review and Evaluation BLA 761102 lymphoblastic adult patients age 1 month to 21 years leukemia in pediatric * For purposes of this review, the proposed product is referred to by either the proposed proprietary name (Asparlas), the proposed proper name (calaspargase pegol-mknl), or the Sponsor’s descriptor
  • Asparlas (calaspargase pegol-mknl) — FDA Purple Book Record (BLA 761102 . . .
    FDA Purple Book record for Asparlas (calaspargase pegol-mknl): BLA 761102, 351(a), applicant Servier Pharmaceuticals LLC, approval date, exclusivity, and marketing status
  • SERVIER PHARMA LLC FDA Approval BLA 761102
    Application #761102 Documents Application Sponsors Marketing Status Application Products FDA Submissions
  • eCFR :: 21 CFR 601. 2 -- Applications for biologics licenses; procedures . . .
    To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600 2 (a) or (b) of this chapter), on forms
  • 761102Orig1s000 - Food and Drug Administration
    EXECUTIVE SUMMARY This review by the Division of Risk Management (DRISK) evaluates whether a risk evaluation and mitigation strategy (REMS) for the new molecular entity (NME) Asparlas (calaspargase pegol) is necessary to ensure the benefits outweigh its risks Baxalta US, Inc , submitted a Biologics License Application (BLA 761102) for calaspargase pegol with the proposed indication as a
  • CENTER FOR DRUG EVALUATION AND RESEARCH - Food and Drug Administration
    Any changes in the manufacturing, testing, packaging, or labeling of ASPARLAS, or in the manufacturing facilities, will require the submission of information to your biologics license application for our review and written approval, consistent with 21 CFR 601 12
  • ASPARLAS (calaspargase pegol-mknl) - Food and Drug Administration
    Please refer to your supplemental biologics license application (sBLA), dated December 26, 2019, received December 26, 2019, and your amendments, submitted under section 351(a) of the Public Health Service Act for ASPARLAS (calaspargase pegol-mknl) intravenous injection
  • 761102Orig1s000 - Food and Drug Administration
    BLA 761102 Calaspargase Pegol – mknl (Asparlas) 3,750 units 5 mL (750 units mL) Injection Servier Pharmaceuticals December 17, 2018 2017-2619-2
  • Purple Book Search
    Asparlas Rx Proper Name calaspargase pegol-mknl BLA Number 761102 Applicant Servier Pharmaceuticals LLC Original Approval Date December 20, 2018 Date of First Licensure
  • Biological Approvals by Year | FDA
    A collection of biological approval information organized by year and regulatory authorities
  • 761102Orig1s000 - accessdata. fda. gov
    A request for proprietary name review for Asparlas should be submitted once the BLA is submitted If any of the proposed product characteristics as stated in your submission, received on December 22, 2017, are altered prior to approval of the marketing application, the name must be resubmitted for review 4 REFERENCES





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