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10 October 2018 Tablets & Capsules USP removes UNII Codes from excipient monographs ROCKVILLE, MD—USP will no longer display unique ingredient identifier (UNII) codes in excipient monographs in the USP–NF online as of November 1, 2018, which coin- cides with the publication of USP 42– NF 37. The organization is seeking to open a dialogue with stakeholders to determine the utility of UNII codes for excipients. Foundations commit $30 million to not-for-profit generic drug manufacturer SALT LAKE CITY, UT—The Laura and John Arnold Foundation, Houston, TX, the Peterson Center on Healthcare, New York, NY, and the Gary and Mary West Foundation, San Diego, CA, have each committed $10 million to founding Civica Rx, a not- for-profit generic drug company that will be headquartered in Salt Lake City. They join seven large US hospi- tal systems, representing approxi- mately 500 hospitals, as governing members of Civica Rx. The company will initially focus on manufacturing 14 hospital-administered generic drugs with the goal of stabilizing the supply of essential medications and expects to release its first products as early as 2019. Briefly noted… The FDA approved Diacomit (stiripentol) to treat seizures associ- ated with Dravet syndrome, a rare form of epilepsy, in patients 2 years of age and older taking clobazam. It i s m a n u f a c t u r e d b y B i o c o d e x , Beauvais, France. T h e a g e n c y a l s o a p p r o v e d Delstrigo (doravirine, lamivudine, and tenofovir disoproxil fumarate) and Pifeltro (doravirine) to treat HIV-1 in adult patients with no prior antiretroviral treatment experience. Both treatments are manufactured by Merck, Kenilworth, NJ. The FDA approved Arakoda (tafenoquine) tablets for the preven- tion of malaria in adult patients. The product, manufactured by 60 Degrees Pharmaceuticals, Washington, DC, is the first malaria prevention the agency has approved in more than 18 years. Boston, MA, and is the first and only approved CFTR modulator for this age group. In other news, the agency also approved Galafold (migalastat) to treat adults with Fabry disease, a rare and serious genetic disease that results from buildup of fat in the blood vessels, kidneys, heart, nerves, and other organs. It is the first oral treatment for this medical condition and is manufactured by Amicus Therapeutics, Cranbury, NJ. FDA approves first child cystic fibrosis treatment, oral treatment for Fabray disease SILVER SPRING, MD—The FDA approved Kalydeco (ivacaftor) to treat cystic fibrosis in children ages 12 to 24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regula- tor (CFTR) gene that is responsive to Kalydeco based on clinical and/or in vitro assay data. The drug is manu- factured by Vertex Pharmaceuticals, HEALTH FROM A DIFFERENT ANGLE CAPSULES ARE THE VERY ESSENCE OF QUALICAPS ® As a company dedicated to capsules we have a unique perspective on how to contribute to health. Qualicaps ® delivers pharmaceutical-grade capsules together with a comprehensive service along the drug product life cycle through our global team of commercial, scientific and technical experts. www.qualicaps.com