VYNDAQEL (tafamidis meglumine capsules) 6 Dosage Forms, Strengths, Composition and Packaging

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Table 1 – Dosage Forms, Strengths, Composition and Packaging

Route of Administration

Dosage Form / Strength/Composition

Non-medicinal Ingredients


Capsule 20 mg: Each soft gelatin capsule (filled with a white to pink suspension) contains 20 mg of micronized tafamidis meglumine (equivalent to 12.2 mg tafamidis)

Ammonium hydroxide 28%, brilliant blue FCF, carmine, gelatin, glycerin, iron oxide (yellow), polyethylene glycol 400, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, sorbitan monooleate, sorbitol, and titanium dioxide.

VYNDAQEL 20 mg: yellow, opaque, oblong (approximately 21 mm) capsule printed with “VYN 20” in red.  120 capsules (one month supply) supplied in 4 intermediary cartons.  Each intermediary carton contains 3 blister cards, with 10 capsules each.