Issue link: https://www.e-digitaleditions.com/i/723777
Tablets & Capsules September 2016 11 Briefly noted… The FDA approved the expansion of the indication for Prezista (darun- avir), which can now be offered to women with HIV-1 during pregnancy and post-partum. Prezista is manufac- tured by Janssen Therapeutics, Titus- ville, NJ. Kayon Partners will form a com- pany with the University of Massa- chusetts-Amherst to commercialize "excipient" foods. The technology enhances the body's ability to absorb drugs and vitamins and may allow individuals to take a lower dose of a drug and experience fewer side effects. The FDA approved Relistor (meth- ylnaltrexone bromide), a once-daily tablet manufactured by Progenics Pharmaceuticals and Valeant Pharma- ceuticals, for treatment of opioid- induced constipation (OIC) in adults with chronic non-cancer pain. Previously, the Agency had approved only subcutaneous injections of the product to treat OIC. Teva agrees to divest 79 products to acquire Allergan generics PETAH TIKVA, ISRAEL—To gain FTC approval of its acquisition of Allergan's generics business, Teva Pharmaceuticals agreed to divest 79 generic products. The purchase brings the number of Teva's product registra- tions pending FDA-approval to 338. It has about 115 pending ANDAs in the USA. It plans to launch 1,500 generics globally in 2017. Mayne Pharma paid about $652 million to acquire 37 approved generic drug products and five awaiting FDA approval from Teva's divesture. They include difficult-to- manufacture, modified-release tablets and capsules and softgels. Nearly a dozen of them will be transferred to Mayne's manufacturing facility in Salisbury, Australia. Check-Cap, GE Healthcare collaborate on x-ray capsule ISFIYA, ISRAEL—Check-Cap, which developed an ingestible capsule for colorectal cancer screening, agreed to develop and validate high-volume manufacturing in collaboration with GE Healthcare. The capsule, which uses ultra-low dose x-ray and wireless communication technologies, scans the inside of the colon as it moves nat- urally while patients follow their nor- mal daily routine. It may eliminate the need for bowel preparation, invasive procedures, and stool handling. Check- Cap is conducting a multi-center clini- cal feasibility study. UL to develop, operate CRN's dietary supplement product registry WASHINGTON, DC—The Coun- cil for Responsible Nutrition (CRN) hired UL to develop and run its dietary supplement product registry, which will provide web-accessible label informa- tion. The registry is undergoing beta testing by several small and large com- panies that have entered their labels into the database. All CRN members will be required to participate in the product registry by July 2017. Cambrex adds API capacity to Iowa site CHARLES CITY, IA—Cambrex, a manufacturer of small-molecule and generic APIs, completed a 7,500- square-foot, $50 million expansion of its GMP-certified site located here. It is one of four large manufacturing facilities at the Charles City site and will handle potent APIs at an OEL as low as 1 microgram per cubic meter. Also included in the expansion is a 36,000-square-foot storage warehouse and another 7,500 square-foot manu- facturing shell that will be equipped to customer specification. FDA approves Gilead's single-tablet hepatitis treatment FOSTER CITY, CA—The FDA approved Gilead Science's Epclusa (sofosbuvir/velpatasvir), the first and only all-oral, pan-genotypic, single- tablet dose for treatment of genotype 1- 6 chronic hepatitis C virus (HCV) infec- tion with or without cirrhosis. It is also the first single-tablet regimen approved for treatment of HCV genotype 2 and 3, without the need for ribavirin.