Pharmaceutical Business review

Sun Pharma wins FDA tentative approval for generic Rilutek

Sun Pharma said that Rilutek (riluzole) is a member of the benzothiazole class. Chemically, riluzole is 2-amino-6-(trifluoromethoxy) benzothiazole.

The generic Riluzole Hydrochloride tablets contain Riluzole Hydrochloride 50mg. Riluzole Hydrochloride tablets are indicated in the treatment of amyotrophic lateral sclerosis.

Riluzole is a white to slightly yellow powder that is soluble in dimethylformamide, dimethylsulfoxide and methanol, freely soluble in dichloromethane, sparingly soluble in 0.1 N HCl and very slightly soluble in water and in 0.1 N NaOH.