Application Nr Approved Date Route Status External Links
NDA016831 2004-12-17 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage: Efudex Is Recommended For The Topical Treatment Of Multiple Actinic Or Solar Keratoses. In The 5% Strength, It Is Also Useful In The Treatment Of Superficial Basal Cell Carcinomas When Conventional Methods Are Impractical, Such As With Multiple Lesions Or Difficult Treatment Sites. Safety And Efficacy In Other Indications Have Not Been Established. The Diagnosis Should Be Established Prior To Treatment, Since This Method Has Not Been Proven Effective In Other Types Of Basal Cell Carcinomas. With Isolated, Easily Accessible Basal Cell Carcinomas, Surgery Is Preferred Since Success With Such Lesions Is Almost 100%. The Success Rate With Efudex Cream And Solution Is Approximately 93%, Based On 113 Lesions In 54 Patients. Twenty-Five Lesions Treated With The Solution Produced 1 Failure And 88 Lesions Treated With The Cream Produced 7 Failures.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
2. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
4. Polysorbate 60 POLYSORBATE 60 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , FEED-Feed additives , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Water WATER Molecular
6. Stearyl Alcohol STEARYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fluorouracil FLUOROURACIL ZINC38212689

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