Issue link: https://www.e-digitaleditions.com/i/1067339
8 January 2019 Tablets & Capsules that lacked competition and 17 com- plex generics. These approvals are part of the agency's efforts to im- prove patient access to high-quality, low-cost pharmaceutical products. Second tissue-agnostic cancer treatment approved by FDA W H I P P A N Y , N J — T h e F D A granted accelerated approval to Vitrakvi (larotrectinib), a cancer treatment for pediatric and adult patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance muta- tion. This is the second tissue-agnos- tic cancer treatment based on a spe- cific common biomarker across different types of tumors rather than the location in the body where the tumor originated. It follows the poli- cies in "Guidance for Industry: Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease," released by the agency in 2018. The product was developed by Bayer and Loxo Oncology, Stamford, CT. FDA approves first LEMS treatment REDWOOD CITY, CA—The FDA approved Firdapse (amifampri- d i n e ) t o t r e a t L a m b e r t - E a t o n Myasthenic Syndrome (LEMS) in adults. The treatment is manufac- tured by Catalyst Pharmaceuticals and is the first treatment for LEMS. Sublingual tablet approved for pain management at healthcare sites REDWOOD CITY, CA—Dsuvia (sufentanil) has been approved by the FDA as the first and only sufentanil sublingual tablet treatment for acute pain in healthcare settings, such as hospitals, surgical centers, and emer- gency departments. It is manufactured by AcelRx Pharmaceuticals. guidances and 41 revised guidances. When these documents are finalized, they will describe the FDA's current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to spe- cific reference-listed drugs. In other news, the FDA an- nounced that it approved 110 ge- neric drugs and tentatively approved 18 generic drugs in October 2018, including 23 first generics for brands industry news FDA seeks input on guidances, approves 110 generics in October SILVER SPRING, MD—The FDA is seeking input on product-specific guidances with the goal of facilitat- ing generic drug development. The agency published 63 product-specific guidances in 2018, including 22 new SANITARY/USDA-ACCEPTED • PNEUMATIC CONVEYING COMPONENTS & SYSTEMS • BATCH & CONTINUOUS OPERATION MULTI-INGREDIENT HANDLING SYSTEMS • BATCH WEIGHING & SCALING SYSTEMS • UL-CONTROLS & CONTROL PACKAGES MOBILE VACUUM CONVEYING SYSTEMS • DIRECT=CHARGE BLENDER, MIXER, REACTOR LOADING SYSTEMS FDA-APPROVED/CERTIFIED MATERIALS OF CONSTRUCTION • 21 CFR PART 11 COMPLIANCE • CIP DESIGNS 69 WILLIAM STREET • BELLEVILLE, NEW JERSEY, USA • (800) VAC-U-MAX • WWW.VAC-U-MAX.COM Let us solve your challenges. Visit www.vac-u-max.com/pneumatic or call (800) VAC-U-MAX. REQUEST-A-QUOTE! More than 60 years of custom application experience in the Pharmaceutical Industry. Over 10,000 different powder & bulk materials conveyed—including free-flowing & non-free flowing powders. Technical expertise including FAT and SAT validation. And an "Airtight Performance Guarantee TM ". It's what makes VAC-U-MAX as unique and trusted as the processing & packaging solutions we design. From sanitary components to automated batch or continuous systems, we create processing & packaging solutions around your needs & goals. Rock Solid Engineering— and a Guarantee to Match. Engineering— Sanitary Vacuum Conveying Solutions for Batch/Continuous Refill Applications including: Feeders, Tablet Presses, Capsule Filling & Packaging Machines, Pharma Extruders, Direct Charge Blender, Mixer, Reactor Loading, In-Line Sieving & more. Visit us at tabletscapsules.com