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LABELS · 2fbc2699-cf99-497c-94b9-8a2c534c061f

Paclitaxel

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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
2023-11-01
Captured
2026-09-09T23:37:42.544548+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. NDA216338
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
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd51ed-29e8-468b-b6d1-21b1f84d6f2e
generic names
  1. PACLITAXEL
id
2fbc2699-cf99-497c-94b9-8a2c534c061f
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. Teva Pharmaceuticals, Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 0480-3290-01
    product ndcs
    1. 0480-3290
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      meta
      disclaimer
      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
      2026-09-09
      results
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      source url
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      spl effective date
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      spl effective time
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      spl version
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      substance names
      1. PACLITAXEL
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      Drugs@FDA application source records
      1. application number
        NDA216338
        payload
        all indexed label documents
        1. Appl No
          216338
          Application Docs Date
          2023-05-12 00:00:00
          Application Docs ID
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          Application Docs Title
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          Application Docs Type ID
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          Submission Type
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          Application Docs Date
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          Application Docs 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
          1
          Submission Status
          AP
          Submission Status Date
          2023-05-11 00:00:00
          Submission Type
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          Submissions Public Notes
        2. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        application number
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        approval interpretation
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        current indication status
        not_reconciled
        has approved submission record
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        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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          Application Docs Type ID
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          Submission No
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          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        TEVA PHARMS INC
        openfda application present
        true
        products
        1. Active Ingredient
          PACLITAXEL
          Appl No
          216338
          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
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      brand names
      1. Paclitaxel
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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. 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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      3. context exact
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      5. context exact
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        true
        exact text
        adjuvant chemotherapy
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        source defined aliases
        1. abbreviation
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          definition exact
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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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        spl effective date
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        spl set id
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        Source null
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        Source null
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        Source null
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        Passage 2 · risk or warning
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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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                              Preserved source evidence · Not medical advice