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TPOXX

NDA 208627 · New Drug Application (NDA) Prescription

TECOVIRIMAT

Sponsor (Drugs@FDA)
SIGA TECHNOLOGIES Company: SIGA TECHNOLOGIES INC (SIGA)
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 208627, with Orange Book listing details
ProductName and ingredientForm and strengthMarketing statusTE codeReferenceOrange Book
001 TPOXX TECOVIRIMAT CAPSULE;ORAL 200MGPrescription– Reference listed drug, Reference standard RXApproved

Submissions

FDA submissions for NDA 208627, newest first
SubmissionStatusStatus dateReviewClassDocuments
Supplement 8ApprovedstandardLabelingLetter for Supplement 8 (opens in a new tab)Label for Supplement 8 (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 6ApprovedstandardEfficacyLetter for Supplement 6 (opens in a new tab)Label for Supplement 6 (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

5 patents listed, as the Orange Book prints them.

Orange Book patents for NDA 208627
PatentExpiresClaimsUse codeSubmitted
8039504Product 001 Drug product –
9339466Product 001 Drug substance, Drug product –
12433868Product 001 Drug product –
7737168Product 001 Method of use U-2346
11890270Product 001 Method of use U-2346

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.

  • TPOXX

    TECOVIRIMAT MONOHYDRATE · SIGA Technologies, Inc. · INTRAVENOUS, ORAL · Version 17 · effective

    Indications and usage

    1 INDICATIONS AND USAGE TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. ( 1.1 ) Limitations of Use: The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. ( 1.2 ) TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models. ( 1.2 ) 1.1 Treatment of Human Smallpox Disease TPOXX ® is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 3 kg. 1.2 Limitations of Use The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled…

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

NDC products

1 product in the NDC directory with this application number.

NDC directory products for NDA 208627
Product NDCNameLabelerForm and routeCategoryMarketing dates
50072-200 in openFDA (opens in a new tab) TPOXX tecovirimat monohydrateSIGA Technologies, Inc. CAPSULE 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.