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10 September 2018 Tablets & Capsules experts worked together to develop these aligned standards to ensure medicine quality. FDA approves endometriosis and HIV-1 treatments S I L V E R S P R I N G , M D — T h e FDA approved Orilissa (elagolix), manufactured by AbbVie, North Chicago, IL. The product is the first and only oral gonadotropin-releas- ing hormone that treats moderate to severe endometriosis pain and is available in once- or twice-daily tablet doses. In other news, the agency also approved Symtuza (darunavir, cobi- cistat, emtricitabine, and tenofovir alafenamide) to treat HIV-1 in treat- ment-naïve and certain virologically suppressed adults. The product, man- ufactured by Janssen Pharmaceutical, Titusville, NJ, is the first and only complete, darunavir-based sin- gle-tablet HIV-1 treatment regimen. Amcor acquires Bemis MELBOURNE, Australia—Amcor, a supplier of rigid and flexible pack- aging for pharmaceutical and nutra- ceutical products, has acquired Bemis, Neenah, WI. The company expects the acquisition to provide increased exposure to attractive markets and a global footprint for their combined healthcare packaging segments. Briefly noted… GlaxoSmithKline, Philadelphia, PA, received FDA approval for Krintafel (tafenoquine), the first sin- gle-dose medication that prevents the relapse of malaria. The agency approved Mulpleta (lusutrombopag) to treat thrombocy- topenia in adults with chronic liver d i s e a s e w h o a r e s c h e d u l e d t o undergo a medical or dental proce- dure. The drug is manufactured by Shionogi, Florham Park, NJ. Agios Pharmaceuticals, Cam- bridge, MA, received FDA approval for Tibsovo (ivosidenib) as a treat- ment for adult patients with relapsed or refractory acute myeloid leukemia who have an IDH1 genetic mutation. for Immediate-Release Solid Oral D o s a g e F o r m s C o n t a i n i n g Biopharmaceutics Classification System Class 1 and 3 Drugs." In other news, the agency also issued a final guidance, "Elemental Impurities in Drug Products," that provides recommendations for con- trolling elemental impurities consis- tent with the ICH Q3D guideline and USP requirements, which went into effect earlier this year. The FDA, ICH, USP, and industry a n d A c c e p t a n c e C r i t e r i a f o r I m m e d i a t e - R e l e a s e S o l i d O r a l D o s a g e F o r m D r u g P r o d u c t s Containing High Solubility Drug Substances." This final guidance pro- vides manufacturers with recommen- dations for submission of NDAs, INDs, and ANDAs for orally admin- istered immediate-release drug prod- ucts that contain highly soluble drug substances. It replaces the August 2015 draft guidance, "Dissolution Testing and Specification Criteria SANITARY/USDA-ACCEPTED • PNEUMATIC CONVEYING COMPONENTS & SYSTEMS • BATCH & CONTINUOUS OPERATION MULTI-INGREDIENT HANDLING SYSTEMS • BATCH WEIGHING & SCALING SYSTEMS • UL-CONTROLS & CONTROL PACKAGES FDA-APPROVED/CERTIFIED MATERIALS OF CONSTRUCTION • 21 CFR PART 11 COMPLIANCE • GEL CAP CONVEYORS MOBILE VACUUM CONVEYING SYSTEMS • CIP DESIGNS • COMBUSTIBLE DUST INDUSTRIAL VACUUM CLEANERS Let us solve your pneumatic conveying challenges. Visit vac-u-max.com/pneumatic or call 800-VAC-U-MAX. With more than 60 years of custom application experience in the pharmaceutical industry. Over 10,000 various powder & bulk materials handled. Technical expertise including FAT & SAT validation. And an airtight performance guarantee. It's what makes VAC-U-MAX as unique & trusted as the process automation solutions we design. From sanitary components to fully automated systems, we create pharmaceutical processing solutions entirely around your needs and goals. VAC-U-MAX MDL105017— Sanitary Vacuum Receiver for fine powders & granules. Booth 8414