Source: FDA, National Drug Code (US) Revision Year: 2023
Lotilaner is a member of the isoxazoline family of compounds. Its chemical name is 2-Thiophenecarboxamide, 5-[(5S)-4,5-dihydro-5-(3,4,5-trichlorophenyl)5(trifluoromethyl)-3-isoxazolyl]-3-methyl-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]-2-thiophenecarboxamide. The molecular formula is C20H14Cl3F6N3O3S. The molecular weight is 596.76 g/mol.
The chemical structure is:
XDEMVY is a sterile, preserved, multi-dose, slightly yellowish, slightly opalescent, topical ophthalmic solution containing lotilaner, 0.25% as the active ingredient. It is preserved with potassium sorbate and contains the following additional inactive ingredients: edetate disodium, hydroxypropyl methylcellulose (HPMC), polyoxyl 35 castor oil, glycerin, dibasic sodium phosphate, monobasic sodium phosphate, and water for injection.
| Dosage Forms and Strengths |
|---|
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XDEMVY (lotilaner ophthalmic solution) is provided as an ophthalmic solution containing lotilaner 0.25% (2.5 mg/mL). |
| How Supplied | ||
|---|---|---|
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XDEMVY is supplied as a sterile ophthalmic solution in a white, opaque, low-density polyethylene (LDPE) multiple-dose bottle with a LDPE dropper tip and tan high-density polyethylene (HDPE) cap.
Manufactured for: Tarsus Pharmaceuticals, Inc., Irvine, CA 92618 |
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