Source: FDA, National Drug Code (US) Revision Year: 2020
EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds.
The chemical structure is:
The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C28H27NO4S•HCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl is an off-white to pale-yellow solid that is very slightly soluble in water.
EVISTA is supplied in a tablet dosage form for oral administration. Each EVISTA tablet contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include anhydrous lactose, carnauba wax, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.
| Dosage Forms and Strengths |
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60 mg, white, elliptical, film-coated tablets (not scored) imprinted with either 4165 or LILLY 4165 on one side in edible blue ink. |
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EVISTA 60 mg tablets are white, elliptical, film coated (not scored) and imprinted with either 4165 or LILLY 4165 on one side in edible blue ink. They are available as follows:
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA |
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| Drug | Countries | |
|---|---|---|
| EVISTA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa |
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