Tablets & Capsules

TC0920

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Tablets & Capsules September 2020 7 treatments. It is manufactured by Chiasma, Needham, MA. ViiV Healthcare, Research Trian- gle, NC, announced that its Rukobia (fostemsavir) antiretroviral medica- tion has been approved by the FDA as an HIV treatment. The drug has been approved to treat adult patients with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies. uct recalls across the supply chain and track-and-trace solutions to meet DSCSA 2023 compliance require- ments. The project involved more than 20 pilot members across indus- tries and functionalities applying and analyzing the success of Tracelink's emerging digital recalls and interop- erable blockchain network solutions. To read the full report, visit www. tracelink.com. FDA publishes revised MAAP on consolidation of ANDAs by OGD SILVER SPRING, MD—The FDA published a revision to the Manual of Policies and Procedures (MAPP 5241.2) that describes the process for reviewing and approving or denying requests to consolidate pre- viously approved abbreviated new drug applications (ANDAs). This revised MAAP applies to the Office of Generic Drugs' (OGD) ANDA consolidation coordinator, regula- tory project managers, and document room staff. FDA publishes temporary guidance on inspections during COVID-19 SILVER SPRING, MD—The FDA published the temporary guidance "Manufacturing, Supply Chain, and Drug and Biological Product Inspec- tions During COVID-19 Public Health Emergency Questions and Answers," providing information related to inspections for facilities manufacturing pharmaceutical prod- ucts and sites involved in the conduct of clinical, analytical, and nonclini- cal studies. The agency recognizes that the pandemic has impacted the drug development programs, ongoing manufacturing operations, and the FDA's ability to conduct inspections and, in response, has developed this guidance to answer some of the most frequently asked questions by spon- sors and applicants. Briefly noted… The FDA has approved Mycapssa (octreotide) as a long-term main- tenance treatment for patients with acromegaly who have responded to and tolerated octreotide or lanreotide PNEUMATIC CONVEYING COMPONENTS & SYSTEMS • FEEDER REFILL SYSTEMS BULK BAG LOADING & UNLOADING SYSTEMS • PACKAGING MACHINE REFILL SYSTEMS MOBILE CONVEYING SYSTEMS • BATCH WEIGHING & SCALING SYSTEMS • CONTROLS 69 William Street • Belleville, NJ 07109 • (800) VAC-U-MAX • info@vac-u-max.com Vacuum convey from handfuls to 3500 lbs/hr of free-flowing and non-free flowing powders and granular materials. Automating Processes. Guaranteed. Let us solve your powder and bulk material handling needs, challenges, and requirements for compliance. Fill out RFQ at www.vac-u-max.com or call (800) VAC-U-MAX. Signature Series TM vacuum receivers for continuous, gentle, dust-free, and hygienic material transfer. Refill Pharmaceutical Feeders Refill Packaging Machines Refill Tablet Presses Refill Blenders/Mixers and more! The FDA approved generic olan- zapine tablets manufactured by Indoco Remedies, Mumbai, India, for treatment of schizophrenia and bipo- lar disorder. The product can also be used with other medications to treat depression and other mental condi- tions. It is the therapeutic equivalent of Zyprexa, which is manufactured by Eli Lilly, Indianapolis, IN.

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