Issue link: https://www.e-digitaleditions.com/i/1067339
10 January 2019 Tablets & Capsules Ribus launches Clean Label Alliance, presents awards ST. LOUIS, MO—Ribus, a sup- plier of rice-based excipients, offi- cially launched the Clean Label Alli- ance at SupplySide West, November 9, 2018. The purpose of the industry group is to assist dietary supplement manufacturers in efficiently produc- ing clean-label supplements by pro- viding resources and solutions from industry leaders. In addition to Ribus, the group includes Biogrund, Bosch Packaging Technology, Lonza, and Natoli Engineering. At the same event, Ribus awarded Gemini Pharmaceuticals, Commack, NY, the Early Adopter Award for producing more than a thousand SKUs using the company's clean-la- bel excipients. The excipient sup- plier also recognized Advanced Orthomolecular Research, Clifton, NJ, as the latest member of the c o m p a n y ' s C e r t i f i e d C o n t r a c t Manufacturer program. FDA approves first bio-identical estradiol and progesterone product BOCA RATON, FL—The FDA approved Bijuva (estradiol and pro- gesterone), the first and only bio- identical hormone therapy combina- tion of estradiol and progesterone. This single, oral capsule for the treat- ment of moderate to severe hot flashes due to menopause is manufac- tured by TherapeuticsMD. FDA approves first new antiviral flu treatment in 20 years OSAKA, Japan—The FDA ap- proved Xofluza (baloxavir marboxil) to treat acute uncomplicated influen- za in patients 12 and older who have exhibited flu symptoms for less than 48 hours. It is the first antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Briefly noted… The FDA approved two drugs to t r e a t a c u t e m y e l o i d l e u k e m i a (AML). Xospata (gilteritinib), manu- factured by Astellas, Northbrook, IL, was approved to treat adult pa- tients who have relapsed or refrac- tory AML with an FLT3 mutation as detected by an FDA-approved test. Daurismo (glasdeg ib), manufac- tured by Pfizer, New York, NY, was approved by the agency for use in combination with low-dose cytara- bine to treat newly-diagnosed AML in adults 75 or older or who have other chronic health conditions or diseases that may preclude the use of intensive chemotherapy. Aemcolo (rifamycin), an anti- bacterial drug manufactured by Cosmo Pharmaceuticals, Dublin, Ireland, was approved by the FDA to treat adult patients with travel- ers' diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.