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Tablets & Capsules July 2020 7 FDA approves pediatric MDR‑TB treatment S I L V E R S P R I N G , M D — T h e FDA approved a new pediatric for- mulation of Sirturo (bedaquiline) as part of a combination therapy to treat pulmonary multidrug-resistant tuberculosis (MDR-TB). The treat- ment is manufactured by Janssen, Titusville, NJ. Briefly noted… The FDA approved AbbVie's Oriahnn, an estrogen and proges- tin combination product comprised of elagolix, estradiol, and norethin- drone acetate, to treat heavy men- strual bleeding caused by uterine leiomyomas (fibroids) in premeno- pausal women. The agency also approved Alun- brig (brigatinib) to treat anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer in adults. It is manufactured by Takeda Phar- maceutical, Tokyo, Japan. The FDA approved Tazverik (tazemetostat) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treat- ment options. It is manufactured by Epizyme, Cambridge, MA. T h e a g e n c y a p p r o v e d X p o - vio (selinexor), to treat adults with relapsed or refractory diffuse large B-cell lymphoma, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. It is manufactured by Karyo- pharm Therapeutics, Newton, MA. The FDA granted Zydus Cadila, Pennington, NJ, approval for its deferasirox product. The drug is used to treat iron overload caused by blood transfusions in adults and children who are at least 2 years old. The drug product is a generic version of Jadenu, which is manufactured by Novartis, Cambridge, MA. Of the new batch of guidances, 24 were developed based on research data generated by the Generic Drug User Fee Amendments Science and Research program. FDA publishes Orange Book draft guidance S I L V E R S P R I N G , M D — T h e F D A p u b l i s h e d , " O r a n g e B o o k Questions and Answers Guidance for Industry," which is intended to help drug product applicants and approved application holders by answering commonly asked ques- tions. The draft guidance covers petitioned Abbreviated New Drug Applications, the movement of drug products between the Active and Discontinued Sections in the Orange Book, and drug product and patent listings. This publica- tion is part of the agency's efforts to improve transparency and provide helpful information to the public and industry. FDA seeks quality benchmarking study participants S I L V E R S P R I N G , M D — T h e FDA is seeking pharmaceutical man- ufacturers to participate in a study on the current state of pharmaceu- tical quality management systems by answering a standardized Qual- ity Benchmarking Study question- naire or attending an onsite inter- view conducted by researchers. The study will be conducted by Dun & Bradstreet and the University of St. Gallen in Switzerland and will run through December. FDA approves pediatric HIV treatment S I L V E R S P R I N G , M D — T h e FDA approved Tivicay (dolutegra- vir) tablets and Tivicay PD (dolute- gravir) tablets for suspension as pedi- atric treatments for HIV-1 infection in combination with other antiretro- viral treatments. The drug products are manufactured by ViiV Health- care, Research Triangle Park, NC. • Lean, dense phase, plug-flow conveying of powders & small particles • Gentle - segregation & damage free • Conveying rates up to 10,000 lbs/hr • Safe, explosion free • Quiet, hygienic, reliable • No tools assembly Simply the best vacuum conveyor 609-265-0101 www.volkmannUSA.com PUT US TO THE TEST Courtesy of Weiss Pharmatechnik GmbH Volkmann_T&C_2C ad-Aug-finaltoprint.indd 1 6/11/20 12:17 PM