The FDA has accepted for review Foamix’s New Drug Application (NDA) for FMX103 (minocycline topical foam 1.5%) topical foam, for the treatment of moderate-to-severe papulopustular rosacea in adults.
David Domzalski, Chief Executive Officer of Foamix, said that FMX103 NDA is another important milestone for the company as it evolves into a fully integrated pharmaceutical company with clinical, development, and commercial capabilities.
“We look forward to working closely with the FDA throughout the review process,” said Domzalski.
According to the CEO, the application includes a strong and complete clinical data package. Domzalski noted rosacea is a challenging condition to treat for patients and healthcare providers, and that if approved, FMX103 has the potential to address significant unmet needs for those who are burdened with rosacea.