Ortho ANDA suitability petition
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%).
You may also be interested in...
The independent, family-controlled German group has signed a third R&D pact with Danish biotech Gubra to develop poly-agonist peptides for obesity.
Inovio Pharmaceuticals has reported promising initial data from its first Phase III study of its electrical current-driven DNA plasmid-based immunotherapy, VGX-3100, in virus-associated cervical dysplasia; it is heading a small group of companies evaluating novel therapies in the condition, which often advances to cancer.
In the month ahead, a key ANDA approval could come for Viatris, while additional competition to Gilead Sciences’ Truvada for PrEP is on the way in the US following Teva and Amneal’s launches.