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After nearly 20 years pioneering the development and commercialization of our innovative platform to bring better quality, convenience, and compliance to the pharmaceutical compounding market, CutisPharma is now a fully-integrated specialty pharmaceutical company with the capability to develop, manufacture and commercialize a broad portfolio of FDA-approved drugs. Building upon our legacy business in the pharmaceutical compounding market, our key focus is on the development of our rich R&D pipeline toward NDA filings with the FDA.
The Company announced on January 29, 2018 that the US Food and Drug Administration (FDA) approved FIRVANQ™ (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.
With our ongoing development collaboration with Dr. Reddy’s Laboratories, we have accelerated our progress in developing RM-02, RM-03 and RM-06 towards NDA filings. We have another program, RM-05, for which clinical studies have been completed and we anticipate NDA filing early next year.