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Tablets & Capsules May 2020 5 hepatitis C virus in children ages 6 years and older or weighing at least 37 pounds with any of the six HCV genotypes—or strains—with- out cirrhosis (liver disease) or with mild cirrhosis. The drug product was previously FDA-approved only for treatment of HCV in adults. It is manufactured by Gilead Sciences, Foster City, CA. The FDA approved Tukysa (tuca- tinib) in combination with chemo- therapy to treat adult patients with advanced forms of HER2-positive breast cancer that can't be removed with surgery or has spread to other parts of the body and who have received one or more prior treat- ments. It is manufactured by Seattle Genetics, Bothell, WA. The agency also approved Pema- zyre (pemigatinib), the first drug approved to treat adults with cer- tain types of previously treated, advanced cholangiocarcinoma, a rare form of cancer in bile ducts. The product is manufactured by Incyte, Wilmington, DE. The FDA approved a generic version of Ancobon (flucytosine), a treatment for fungal infections. The generic is manufactured by Strides Pharma Science, Singapore. Anco- bon is manufactured by Bausch Health, Laval, QC. quality overview, and a supply chain and security overview. The guide can be downloaded at ipecamericas.org. ISPE announces FOYA winners NORTH BETHESDA, MD— The International Society for Phar- m a c e u t i c a l E n g i n e e r i n g ( I S P E ) announced the 2020 Facility of the Year Awards (FOYA) category winners, which include F. Hoff- mann-La Roche, Pfizer, Sanofi, Eli Lilly, Janssen Pharmaceuticals, Bristol-Myers Squibb, GlaxoSmith- Kline, and United Therapeutics. The panel of judges also awarded honorable mentions to Boehringer I n g e l h e i m B i o p h a r m a c e u t i c a l s China and Janssen Pharmaceuti- cals. The awards program recog- nizes innovation and creativity in manufacturing facilities serving the regulated healthcare industry. Briefly noted… The FDA approved Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with metastatic col- orectal cancer with a BRAF V600E mutation after prior therapy. It is manufactured by Array BioPharma, Boulder, CO. The agency also approved a sup- plemental application for Epclusa (sofosbuvir and velpatasvir) to treat of the program and the college's accreditation, the move has paved the way for the students to pur- sue their licensure exams and allows them to work as graduate pharma- cists until receiving licensure. USP changes compendial reference title ROCKVILLE, MD—USP will transition to a new naming con- vention for its USP–NF compendial reference standards, based on the evaluation of public comments and pending approval of its Council of Experts. The forthcoming publication in November formerly known as USP 44–NF 39 will be published as USP– NF 2021 Issue 1. Moving forward, the thrice-yearly publication will follow the year-based naming convention followed by the issue number. IPEC publishes revised EIP ARLINGTON, VA—The Inter- national Pharmaceutical Excipients Council Federation, (IPEC Federa- tion) has published its revised Excip- ient Information Package User Guide And Template (EIP), which was orig- inally published in 2005, and revised in 2009 and 2013. The EIP guide is meant to facilitate information shar- ing between excipient suppliers and users. It consists of three documents: a product regulatory datasheet, a site The Solids Flow Experts If you have a Particle, We can Characterize it Dedicated to providing cost effec�ve engineered solu�ons based on measure- ment of key material flow proper�es. We can combine material flow property tes�ng with nearly 40 years consul�ng experience to solve any flow and han- dling problems facing today's producers of fine powders and granules. C u s t o m D es i g n s Call us: +1-352-379-8879 Visit us: www.ma�lowsol.com