Source: FDA, National Drug Code (US) Revision Year: 2024
OJEMDA contains tovorafenib, a kinase inhibitor. Tovorafenib has the molecular formula C17H12Cl2F3N7O2S and a molecular weight of 506.29. The chemical name for tovorafenib is 6-amino-5-chloro-N-[(1R)1[5-[[[5-chloro-4-(trifluoromethyl)-2-pyridinyl]amino]carbonyl]-2-thiazolyl]ethyl]-4-pyrimidinecarboxamide. Tovorafenib has the following chemical structure:
It is a white to off-white powder. The solubility of tovorafenib at 37ºC is ≤ 3 micrograms/mL from pH 1.2 to 8 in aqueous media.
OJEMDA (tovorafenib) tablets are supplied as 100 mg strength tablets for oral administration. Each tablet contains 100 mg tovorafenib and the following inactive ingredients: copovidone, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and Opadry Orange.
OJEMDA (tovorafenib) for oral suspension is a white to off white powder which produces a white suspension when reconstituted with water. Each mL of reconstituted tovorafenib suspension contains 25 mg of tovorafenib and the following inactive ingredients: artificial strawberry flavor, colloidal silicon dioxide, copovidone, maltodextrin, mannitol, microcrystalline cellulose, simethicone, sodium lauryl sulfate, and sucralose.
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Tablets:
For Oral Suspension:
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OJEMDA tablets: 100 mg: orange, film-coated, oval tablets debossed with “100” on one side and “D101” on the opposite side and supplied as follows: 4 blister cards (4 tablets each) per box, NDC 82950-001-16. 5 blister cards (4 tablets each) per box, NDC 82950-001-20. 4 blister cards (6 tablets each) per box, NDC 82950-001-24. OJEMDA for oral suspension: 25 mg/mL: white to off white powder in a clear glass bottle, co-packaged with a press-in bottle adaptor and a 20 mL oral dosing syringe (NDC# 82950-012-01). Each mL of reconstituted, strawberry flavored tovorafenib suspension contains 25 mg of tovorafenib. Each bottle delivers 300 mg of tovorafenib in 12 mL. Manufactured for: Day One Biopharmaceuticals, Inc., 2000 Sierra Point Parkway, Suite 501, Brisbane CA 94005 Manufactured by (tablets): Quotient Sciences – Philadelphia LLC, 3 Chelsea Parkway, Suite 305, Boothwyn PA 19061 Manufactured by (oral suspension): Quotient Sciences – Philadelphia LLC, 3080 McCann Farm Dr., Garnet Valley, PA 19060 |
| Drug | Countries | |
|---|---|---|
| OJEMDA | United States |
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