Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne
FOAMIX PHARMACEUTICALS LTD (FOMX)
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Source: GlobeNewswire
REHOVOT, Israel and BRIDGEWATER, N.J., Dec. 21, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for FMX101 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older. “Submission of this NDA is yet another important milestone for Foamix, and potentially brings us one step further to commercial launch of FMX101,” commented David Domzalski, Chief Executive Officer. “We are making this submission following successful efficacy and safety outcomes in our Phase 3 program for FMX101 and incorporating guidance received from the FDA in a Type B pre-NDA meeting held earlier in 2018. We look forward to working with the
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