TASMARÒ
(tolcapone)
DESCRIPTION
TASMARÒ is available as tablets containing 100 mg or 200 mg tolcapone.
Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used in the treatment of Parkinson¡¯s disease as an adjunct to levodopa/carbidopa therapy. It is a yellow, odorless, non-hygroscopic, crystalline compound with a relative molecular mass of 273.25. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone. Its empirical formula is C14H11NO5 and its structural formula is:
Inactive ingredients: Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone K-30, sodium starch glycolate, talc and magnesium stearate. Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethylcellulose, triacetin and sodium lauryl sulfate, with the following dye systems: 100 mg ¡ª yellow and red iron oxide; 200 mg ¡ª red iron oxide.
REFERENCES
1 Revised to present current information since FDA approval of NDA 20-697 for TasmarÒ (tolcapone) Tablets on January 29, 1998.
2Information was updated based on the telephone discussion and agreement made by FDA on February 7, 2006.
3Information was revised according to Tables 3 and 4 of Valeant¡¯s General Correspondence: Briefing Package for a Type B Meeting which was submitted to FDA on April 15, 2005 and discussed with FDA on May 9, 2005 (refer to ATTACHMENT B). According to the data presented in Tables 3 and 4, the overwhelming majority of SGPT/ALT or SGOT/ASTelevations occurred in the first 6 months.
4Based on the discussion and agreement made by FDA on May 9, 2005, FDA recommended that Valeant use MedPointe Pharmaceuticals¡¯ FelbatolÒ (felbamate) Tablet package insert (see ATTACHMENT A) as a guideline to revise Valeant¡¯s labeling.
