Source: FDA, National Drug Code (US) Revision Year: 2018
TPOXX (tecovirimat) is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein. TPOXX is available as immediate release capsules containing tecovirimat monohydrate equivalent to 200 mg of tecovirimat for oral administration. The capsules are imprinted in white ink with “SIGA” followed by the SIGA logo followed by “R” on an orange body, and a black cap imprinted in white ink with “ST-246”. The capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell is composed of gelatin, FD&C blue #1, FD&C red #3, FD&C yellow #6, and titanium dioxide.
Tecovirimat monohydrate is a white to off-white crystalline solid with the chemical name Benzamide, N-[(3aR,4R,4aR,5aS,6S,6aS)-3,3a,4,4a,5,5a,6,6a-octahydro-1,3-dioxo-4,6 ethenocycloprop[f]isoindol-2(1H)-yl]4(trifluoromethyl), rel-(monohydrate). The chemical formula is C19H15F3N2O3·H2O representing a molecular weight of 394.35 g/moL.
The molecular structure is as follows:
Tecovirimat monohydrate is practically insoluble in water and across the pH range of 2.0-6.5 (<0.1 mg/mL).
| Dosage Forms and Strengths |
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TPOXX capsules are hard gelatin with an opaque orange body imprinted in white ink with “SIGA” followed by the SIGA logo followed by “R trademark”, and an opaque black cap imprinted in white ink with “ST-246”, containing white to off-white powder. Each capsule contains 200 mg of tecovirimat. |
| How Supplied |
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Each TPOXX capsule contains 200 mg of tecovirimat. TPOXX capsules are hard gelatin with an opaque orange body imprinted in white ink with “SIGA” followed by the SIGA logo followed by “R trademark”, and an opaque black cap imprinted in white ink with “ST-246”, containing white to off-white powder. Each bottle contains 42 capsules (NDC 50072-200-42) with an induction seal and child-resistant cap. |
| Drug | Countries | |
|---|---|---|
| TPOXX | United States |
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