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NERLYNX

NDA 208051 · New Drug Application (NDA) Prescription

NERATINIB MALEATE

Sponsor (Drugs@FDA)
PUMA BIOTECH Company: PUMA BIOTECHNOLOGY, INC. (PBYI)
First approved
Latest action

Drugs on HealthTrade

Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.

Products

Drugs@FDA products under NDA 208051, with Orange Book listing details
ProductName and ingredientForm and strengthMarketing statusTE codeReferenceOrange Book
001 NERLYNX NERATINIB MALEATE TABLET;ORAL EQ 40MG BASEPrescription– Reference listed drug, Reference standard RXApproved

Submissions

FDA submissions for NDA 208051, newest first
SubmissionStatusStatus dateReviewClassDocuments
Supplement 9ApprovedstandardEfficacyLetter for Supplement 9 (opens in a new tab)Label for Supplement 9 (opens in a new tab)
Supplement 7ApprovedstandardEfficacyLetter for Supplement 7 (opens in a new tab)Label for Supplement 7 (opens in a new tab)
Supplement 5ApprovedstandardEfficacyLetter for Supplement 5 (opens in a new tab)Label for Supplement 5 (opens in a new tab)
Supplement 6ApprovedstandardEfficacyLetter for Supplement 6 (opens in a new tab)Label for Supplement 6 (opens in a new tab)
Supplement 4ApprovedstandardEfficacyLetter for Supplement 4 (opens in a new tab)Label for Supplement 4 (opens in a new tab)
Supplement 3ApprovedstandardLabelingLetter for Supplement 3 (opens in a new tab)
Supplement 2ApprovedstandardLabelingLetter for Supplement 2 (opens in a new tab)Label for Supplement 2 (opens in a new tab)
Original 1ApprovedstandardType 1 - New Molecular EntityLetter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab)

Orange Book patents

20 patents listed, as the Orange Book prints them.

Orange Book patents for NDA 208051
PatentExpiresClaimsUse codeSubmitted
10035788Product 001 Method of use U-2043
10035788Product 001 Method of use U-3047
10035788Product 001 Method of use U-3097
9139558Product 001 Method of use U-2043
9139558Product 001 Method of use U-3047
9139558Product 001 Method of use U-3097
9630946Product 001 Method of use U-2043
9630946Product 001 Method of use U-3047
9630946Product 001 Method of use U-3097
9265784Product 001 Method of use U-3047
9211291Product 001 Method of use U-2043
9211291Product 001 Method of use U-3097
8790708Product 001 Drug product U-2043
8790708Product 001 Drug product U-3047
8790708Product 001 Drug product U-3097
8518446Product 001 Drug product U-2043
8518446Product 001 Drug product U-3047
8518446Product 001 Drug product U-3097
7399865Product 001 Drug substance, Drug product –
8669273Product 001 Method of use U-3047

Orange Book exclusivities

No Orange Book exclusivities are listed for this application.

Prescription labels

The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.

  • Nerlynx

    NERATINIB · Puma Biotechnology, Inc. · ORAL · Version 19 · effective

    Indications and usage

    1 INDICATIONS AND USAGE NERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. ( 1.1 ) In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. ( 1.2 ) 1.1 Extended Adjuvant Treatment of Early-Stage Breast Cancer NERLYNX as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy [see Clinical Studies ( 14.1 )] . 1.2 Advanced or Metastatic Breast Cancer NERLYNX in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more…

    Full label on DailyMed for Nerlynx (opens in a new tab)

NDC products

1 product in the NDC directory with this application number.

NDC directory products for NDA 208051
Product NDCNameLabelerForm and routeCategoryMarketing dates
70437-240 in openFDA (opens in a new tab) Nerlynx neratinibPuma Biotechnology, Inc. TABLET ORALNDA From

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Sources

Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”

Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.