Tablets & Capsules

TC0416

Issue link: https://www.e-digitaleditions.com/i/666166

Contents of this Issue

Navigation

Page 13 of 71

Visit us at INTERPHEX 2016 Booth 1862 New York2/2NY, USA April 262-228, 2016 YOUR BENEFITS > High accuracy feeders for optimal ingredient delivery > Innovative sanitary and hygienic pneumatic conveying solutions > ZSK twin screw extruders suitable for the continuous production of pharmaceutical compounds > Integrated systems controls for all operations > All systems designed with advanced pharmaceutical-grade engineering >>2Accuracy at every process step. Feeding, weighing, conveying and extrusion systems provided by Coperion and Coperion K-Tron oP er the highest in eQ ciency and reliability to ensure the optimum in product eQ cacy. >>2www.coperion-pharma.com >+extruders >+feeders >+components >+pneumatic conveying >+complete systems industry news Amarin's right to promote off-label use affirmed WASHINGTON, DC—Amarin, Dublin, Ireland, reached a settlement with the FDA that affirms Amarin may promote off-label use of Vascepa (icos- apent ethyl) capsules. The FDA had ruled against Amarin's request to expand promotion of Vascepa, and the company filed suit against the Agency in May 2015 claiming infringement of is right to free speech. A judge had ruled in favor of the company in August 2015. FDA's final rule confirms safety of gelatin WASHINGTON, DC—The FDA issued a final rule to reduce the risk of bovine spongiform encephalopa- thy or "mad cow disease," prohibiting the use of certain cattle material in dietary supplements and foods. The rule also provides a definition of gelatin and clarifies that gelatin is not considered a prohibited cattle mater- ial if it is manufactured using the cus- tomary industry processes specified. Gelatin was never considered a pro- hibited cattle material, but the FDA had never specifically defined gelatin. Furthermore, the rule con- firms that milk and milk products are not prohibited cattle materials. USP updates general chapter on elemental impurities WASHINGTON, DC—USP has proposed revisions to general chapter <232> on elemental impurities so it better aligns with ICH Q3D. The revised text cites additional elements and their specific limits. It also clari- fies what information excipient sup- pliers must provide to customers and what information is optional. For instance, excipient suppliers are not required to perform elemental impu- rity testing or provide information about elements unless the elements are listed in a USP or NF excipient monograph. More information is available here: http://bit.ly/uspEIrev. USP will accept comments about the revisions until May 30. Sanofi, DiCE reach $2.3 billion deal PARIS, FRANCE—Sanofi, France's largest pharmaceutical manufacturer, and DiCE Molecules, a new company based in San Franciso, CA, agreed to cooperate in developing small-mole- cule compounds. The agreement, worth as much as $2.3 billion, calls for a 5-year effort to find oral dosage alternatives to parenteral delivery for certain diseases. The companies will work together on as many as 12 drug targets, with Sanofi contributing $184 million per target. Gilead gains FDA approval for Odefsey tablet FOSTER CITY, CA—The FDA approved Gilead's Odefsey (emtric- itabine, rilpivirine, and tenofovir alafenamide) as an HIV-1 treatment 10 April 2016 Tablets & Capsules

Articles in this issue

Links on this page

Archives of this issue

view archives of Tablets & Capsules - TC0416