The FDA announced the approval for the first generic of Oxistat cream, 1% for treating athlete’s foot, jock itch, ringworm and tinea versicolor due to Malassezia furfur.
Common side effects of oxiconazole nitrate cream, 1% reported in clinical trials included pruritus, burning, irritation and allergic contact dermatitis, folliculitis, erythema, and papules, fissure, maceration, rash, stinging, and nodules, according to a drug information update from the FDA.
A medication guide for patients is required for the dispensing of Oxistat cream, which must be used as directed by a physician and is for external dermal use only, according to the update.
Patients should notify a physician if there is no improvement after 2 to 4 weeks, or sooner if the condition worsens or there are signs of increased irritation, itching, blistering, swelling or oozing, the FDA reported. The drug label contains additional information on oxiconazole nitrate cream, 1%, with drug labels of FDA approved drug products searchable at Drugs@FDA.