The system, to be established by the US Securities and Exchange Commission (SEC) and the North American Securities Administrators Association (NASAA)(1), will be based on technology used in the new Web-based Central Registration Depository (CRD) coming on line later this month.
Minivelle is currently the smallest estrogen patch available at 2.48cm 2 per patch (about 34% smaller than Vivelle-Dot). Minivelle contains bioidentical estradiol, a plant-based estrogen that is chemically identical to the estrogen produced naturally by a woman's body.
FDA Approves First US Biosimilar; Hold Your Breath On Cost Savings. In a much-anticipated decision, the Food and Drug Administration announced this morning the approval of filgrastim-sndz, the first non-brand, complex biopharmaceutical â or biosimilar â in US pharmaceutical history. The drug, made by Sandoz, will be sold in the US under the much simpler* brand name, Zarxio.