Ortho ANDA suitability petition
Executive Summary
Miconazole nitrate 2% and betamethasone dipropionate 0.05% cream is not suitable for ANDA review, FDA told Ortho. Miconazole nitrate has never been approved in combination with any other active ingredient and "interactions of the proposed active ingredients raise the question of clinical effectiveness and possible adverse effects," the agency explained. Ortho said the reference drug is Schering's Lotrisone (clotrimazole 1% and betamethasone dipropionate 0.05%).