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HIV treatment regimen containing only two APIs. T h e A g e n c y a l s o a p p r o v e d Isentress (raltegravir) in combination with other antiretroviral agents for treatment of HIV-1 in newborns from birth to 4 weeks of age. It is manufac- tured by Merck, Kenilworth, NJ. Guidance addresses opioid abuse deterrence studies SILVER SPRING, MD—The FDA published "Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products." It rec- ommends studies—such as compara- tive in vitro and pharmacokinetic studies—that applicants should con- duct to demonstrate to the Agency that its generic product is no less abuse deterrent than the refer- ence-listed drug for all potential routes of abuse. For more informa- t i o n , s e e t h e a r t i c l e b y A l y n McNaughton on page 17. FDA approves first ECD treatment SILVER SPRING, MD—The FDA expanded the indication for Zelboraf (vemurafenib) to treat adult patients with Erdheim-Chester Disease (ECD), a rare blood cancer. The tablet is the first approved ECD treatment. The product was already approved to treat patients whose cancer cells have a spe- cific genetic mutation known as BRAF V600. It is manufactured by Hoffman- LaRoche, Basel, Switzerland. Briefly noted… T h e F D A a p p r o v e d P f i z e r ' s Sutent (sunitinib malate) for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. T h e A g e n c y a l s o a p p r o v e d Allergan's Vraylar (cariprazine) for maintenance treatment of adults with schizophrenia. It is already approved for acute treatment of manic or mixed episodes of bipolar disorder. Tablets & Capsules January 2018 9 Follow us on Twitter @TabletsCapsules 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 MOBILE VACUUM CONVEYING SYSTEMS • CIP DESIGNS Let us solve your pneumatic conveying challenges. Visit vac-u-max.com/pneumatic or call 800-VAC-U-MAX. More than 60 years of custom application experience in the pharmaceutical industry. Over 10,000 different powder and bulk materials handled—including Free-Flowing and Non-Free Flowing Powders. Technical expertise including FAT and SAT validation. And an airtight perfor- mance guarantee. It's what makes VAC-U-MAX as unique and trusted as the pharmaceutical process automation solutions we design. From sanitary components to fully automated batch or continuous systems, we create pharmaceutical processing solutions entirely around your needs and goals. VAC3509 Product 4.5625 x 7.5 PC PHARMA TC 1-USA.indd 1 10/4/2016 12:48:47 PM