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SPINRAZA

NDA 209531 · New Drug Application (NDA) Prescription

NUSINERSEN SODIUM

Sponsor (Drugs@FDA)
BIOGEN Company: BIOGEN INC. (BIIB)
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 209531, with Orange Book listing details
ProductName and ingredientForm and strengthMarketing statusTE codeReferenceOrange Book
001 SPINRAZA NUSINERSEN SODIUM SOLUTION;INTRATHECAL EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)Prescription– Reference listed drug, Reference standard RXApproved
002 SPINRAZA NUSINERSEN SODIUM SOLUTION;INTRATHECAL EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)Prescription– Reference listed drug, Reference standard RXApproved
003 SPINRAZA NUSINERSEN SODIUM SOLUTION;INTRATHECAL EQ 50MG BASE/5ML (EQ 10MG BASE/ML)Prescription– Reference listed drug, Reference standard RXApproved

Submissions

FDA submissions for NDA 209531, newest first
SubmissionStatusStatus dateReviewClassDocuments
Supplement 16ApprovedstandardEfficacyLetter for Supplement 16 (opens in a new tab)Label for Supplement 16 (opens in a new tab)
Supplement 13ApprovedstandardLabelingLetter for Supplement 13 (opens in a new tab)Label for Supplement 13 (opens in a new tab)
Supplement 14ApprovedstandardLabelingLetter for Supplement 14 (opens in a new tab)Label for Supplement 14 (opens in a new tab)
Supplement 11ApprovedstandardLabelingLetter for Supplement 11 (opens in a new tab)Label for Supplement 11 (opens in a new tab)
Supplement 10ApprovedstandardEfficacyLetter for Supplement 10 (opens in a new tab)Label for Supplement 10 (opens in a new tab)
Supplement 7ApprovedstandardLabelingLetter for Supplement 7 (opens in a new tab)Label for Supplement 7 (opens in a new tab)
Supplement 8ApprovedstandardLabelingLetter for Supplement 8 (opens in a new tab)Label for Supplement 8 (opens in a new tab)
Supplement 5ApprovedstandardLabelingLetter for Supplement 5 (opens in a new tab)Label for Supplement 5 (opens in a new tab)
Supplement 3ApprovedstandardEfficacyLetter for Supplement 3 (opens in a new tab)Label for Supplement 3 (opens in a new tab)
Supplement 4ApprovedstandardLabelingLetter for Supplement 4 (opens in a new tab)Label for Supplement 4 (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 1ApprovedpriorityType 1 - New Molecular EntityLetter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab)

Orange Book patents

34 patents listed, as the Orange Book prints them.

Orange Book patents for NDA 209531
PatentExpiresClaimsUse codeSubmitted
7838657Product 001 Drug substance –
9717750Product 001 Method of use U-1942
9717750Product 001 Method of use U-1943
9717750Product 001 Method of use U-2093
9717750Product 001 Method of use U-2094
8980853Product 001 Method of use U-1941
8361977Product 001 Drug substance, Drug product –
9926559Product 001 Method of use U-1943
10436802Product 001 Method of use U-1941
10436802Product 001 Method of use U-1942
10436802Product 001 Method of use U-1943
10436802Product 001 Method of use U-1944
10436802Product 001 Method of use U-2093
10436802Product 001 Method of use U-2094
12013403Product 001 Method of use U-1941
12013403Product 001 Method of use U-1942
12013403Product 001 Method of use U-1943
12013403Product 001 Method of use U-1944
12013403Product 001 Method of use U-2093
12013403Product 001 Method of use U-2094
7838657Product 002 Drug substance, Drug product –
9717750Product 002 Method of use U-1942
9717750Product 002 Method of use U-1943
9717750Product 002 Method of use U-2093
9717750Product 002 Method of use U-2094
8980853Product 002 Method of use U-1941
8361977Product 002 Drug substance, Drug product –
7838657Product 003 Drug substance, Drug product –
9717750Product 003 Method of use U-1942
9717750Product 003 Method of use U-1943
9717750Product 003 Method of use U-2093
9717750Product 003 Method of use U-2094
8980853Product 003 Method of use U-1941
8361977Product 003 Drug substance, Drug product –

Orange Book exclusivities

Orange Book exclusivities for NDA 209531
CodeProductExpires
NS002
NS003

Codes as the Orange Book prints them; its preface explains each code.

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.

  • Spinraza

    NUSINERSEN · Biogen Inc. · INTRATHECAL · Version 21 · effective

    Indications and usage

    1 INDICATIONS AND USAGE SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients ( 1 )

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

NDC products

3 products in the NDC directory with this application number.

NDC directory products for NDA 209531
Product NDCNameLabelerForm and routeCategoryMarketing dates
64406-036 in openFDA (opens in a new tab) Spinraza NusinersenBiogen Inc. INJECTION, SOLUTION INTRATHECALNDA From
64406-037 in openFDA (opens in a new tab) Spinraza NusinersenBiogen Inc. INJECTION, SOLUTION INTRATHECALNDA From
64406-058 in openFDA (opens in a new tab) Spinraza NusinersenBiogen Inc. INJECTION, SOLUTION INTRATHECALNDA From

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FDA drug shortages load here.

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.