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LABELS · 5db1c7ab-35c2-4764-b1ae-33f44560883b

PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2023-05-01
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SEVERE MYELOSUPPRESSION Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) therapy to patients who have baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications ( 4 )]. Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions ( 5.1 , 5.3 )]. Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 , 5.3 )]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning. Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) Monitor for neutropenia, which may be severe and result in infection or sepsis. ( 5.1 , 5.3 ) Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). ( 5.1 , 5.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. ( 1.3 ) 1.1 Metastatic Breast Cancer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 1.2 Non-Small Cell Lung Cancer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. 1.3 Adenocarcinoma of the Pancreas Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
Full extracted label fields
application numbers
  1. NDA211875
boxed warning exact
  1. WARNING: SEVERE MYELOSUPPRESSION Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) therapy to patients who have baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications ( 4 )]. Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions ( 5.1 , 5.3 )]. Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 , 5.3 )]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning. Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) Monitor for neutropenia, which may be severe and result in infection or sepsis. ( 5.1 , 5.3 ) Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). ( 5.1 , 5.3 )
brand names
  1. PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f06d1bb3-83f1-4d84-8004-4c6681ad8a5a
generic names
  1. PACLITAXEL
id
5db1c7ab-35c2-4764-b1ae-33f44560883b
indications and usage exact
  1. 1 INDICATIONS AND USAGE Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. ( 1.3 ) 1.1 Metastatic Breast Cancer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 1.2 Non-Small Cell Lung Cancer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. 1.3 Adenocarcinoma of the Pancreas Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. American Regent, Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 0517-4300-01
    product ndcs
    1. 0517-4300
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
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      url
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      source url
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      spl effective date
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      spl effective time
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      substance names
      1. PACLITAXEL
      uniis
      1. P88XT4IS4D
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      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        NDA211875
        payload
        all indexed label documents
        1. Appl No
          211875
          Application Docs Date
          2022-07-28 00:00:00
          Application Docs ID
          71661
          Application Docs Title
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          Application Docs Type ID
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          Submission No
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        all submission records
        1. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
          15
          Submission No
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          Submission Status
          AP
          Submission Status Date
          2022-07-27 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
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        approval interpretation
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        current indication status
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        has approved submission record
        true
        latest approved submission date
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        latest label selection rule
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        latest posted label documents
        1. Appl No
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          Application Docs Date
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          Application Docs ID
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          Application Docs Title
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          Submission No
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        AM REGENT
        openfda application present
        true
        products
        1. Active Ingredient
          PACLITAXEL
          Appl No
          211875
          Drug Name
          PACLITAXEL
          Form
          POWDER;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          100MG/VIAL
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. NDA211875
      brand names
      1. PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND
      classification reasons
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      clinical review status
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      content role
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      context span
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      503
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combinatio
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      is a microtubule inhibitor indicated
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      qualifier mentions
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        is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic d
        kind
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        polarity
        not_inferred
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        Metastatic breast cancer
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      2. context exact
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        end exclusive
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      3. context exact
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        kind
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        Metastatic breast cancer
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      4. context exact
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      5. context exact
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        end exclusive
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        adjuvant chemotherapy
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      regulatory links
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        source batch sha256
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        source defined aliases
        1. abbreviation
          NSCLC
          definition exact
          non-small cell lung cancer
          definition span
          end
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          end exclusive
          true
          exact text
          non-small cell lung cancer (NSCLC)
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        1 INDICATIONS AND USAGE Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
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        Source null
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        disease stage
        Source null
        limitations
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        Source null
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        Source null
        regimen
        Source null
        tumor histology
        Source null
        use intent
        tumor_directed_candidate
        Passage 2 · risk or warning
        application numbers
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        brand names
        1. PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND
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        a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiatio
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            Passage 3 · unclassified context
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            1. PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND
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            failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. ( 1.3 ) 1.1 Metastatic Breast Cancer Paclitaxel Protein-Bound Particles for Injectable Susp
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            positive predicate support span
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            1. context exact
              ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin,
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            3. context exact
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              kind
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                              Preserved source evidence · Not medical advice