Source: FDA, National Drug Code (US) Revision Year: 2023
Trofinetide is designated chemically as (2S)2{[(2S)1(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid (IUPAC). Its empirical formula is C13H21N3O6 and its molecular weight is 315.33 g/mol.
The chemical structure is:
Trofinetide is a white to off-white solid and is freely soluble in water.
DAYBUE is a pink to red, oral solution with each 5 mL containing 1 g of trofinetide (200 mg/mL). The oral solution also contains FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose as inactive ingredients.
| Dosage Forms and Strengths |
|---|
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Trofinetide oral solution: 200 mg/mL of a pink to red, strawberry flavored solution. |
| How Supplied |
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DAYBUE (trofinetide) 200 mg/mL oral solution is a pink to red, strawberry flavored solution supplied in a nominal 500 mL round high-density polyethylene (HDPE) multi-dose bottle with a child-resistant closure containing 450 mL of oral solution (NDC 63090-660-01). Marketed by: Acadia Pharmaceuticals Inc. San Diego, CA 92130 USA |
| Drug | Countries | |
|---|---|---|
| DAYBUE | United States |
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