Antifungal Skin Treatment Gets First Generic Approval
The first generic for Oxistat Cream (oxiconazole nitrate) 1% has been approved by the FDA. The topical cream is indicated for the treatment of tinea pedis, tinea cruris, tinea corporis (due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum) and tinea (pityriasis) versicolor due to Malassezia furfur. It may be used in pediatric patients however, these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below the age of 12.
Oxiconazole nitrate is an imidazole derivative whose antifungal activity is derived primarily from the inhibition of ergosterol biosynthesis, which is critical for cellular membrane integrity.
The cream must be dispensed with a Medication Guide for patients, which provides important information about the medication's use and risks.
For more information visit FDA.org.