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Manufacturer Warnings

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FDA Labeling Changes

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LATUDA is indicated for the treatment of patients with schizophrenia.

The efficacy of LATUDA in schizophrenia was established in four 6-week controlled studies of adult patients with schizophrenia [see Clinical Studies (14.1)].

The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2)].


There is currently no drug history available for this drug.

Other Information

LATUDA is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives.

Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14.

The chemical structure is:

chemical structure

Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone.

LATUDA tablets are intended for oral administration only. Each tablet contains 40 mg, or 80 mg of lurasidone hydrochloride.

Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No.2 Aluminum Lake.

Latuda Manufacturers

  • Bushu Pharmaceutical, Ltd.
    Latuda (Lurasidone Hydrochloride) Tablet, Film Coated [Bushu Pharmaceutical, Ltd.]
  • Sunovion Pharmaceuticals Inc.
    Latuda (Lurasidone Hydrochloride) Tablet, Film Coated [Sunovion Pharmaceuticals Inc.]

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