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Brentuximab vedotin [6] consists of the chimeric monoclonal antibody brentuximab (cAC10, which targets the cell-membrane protein CD30) linked with maleimide attachment groups, cathepsin-cleavable linkers (valine-citrulline), and para-aminobenzylcarbamate spacers to three to five units of the antimitotic agent monomethyl auristatin E (MMAE, reflected by the 'vedotin' in the drug's name). [7]
Although the Federal Food, Drug, and Cosmetic Act made it possible for generic companies to get regulatory approval for drugs by filing an Abbreviated New Drug Application (ANDA), in the early 1980s it became clear that very few generics were coming to market. Congress studied the issue and realized that under patent and regulatory law it was ...
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The combination fluticasone furoate/umeclidinium bromide/vilanterol product is approved by the US Food and Drug Administration with an indication for the maintenance treatment of a chronic lung problem called chronic obstructive pulmonary disease (COPD) in adults who (1) have already tried fluticasone furoate/vilanterol (brand name Breo Ellipta) but are still experiencing symptoms of airway ...
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Dronedarone has been termed a "multichannel blocker". [citation needed] However, it is unclear which channel(s) play a pivotal role in its success. [9]Thus, dronedarone's actions at the cellular level are controversial, with most studies suggesting an inhibition in multiple outward potassium currents including rapid delayed rectifier, slow delayed rectifier and ACh-activated inward rectifier. [10]
The FDA granted the application of polatuzumab vedotin breakthrough therapy, priority review, and orphan drug designations. [9] The FDA granted the approval of Polivy to Genentech. [9] Polatuzumab vedotin was approved for medical use in the European Union in January 2020, as a second-line treatment. [7]
Deflazacort's potency is around 70–90% that of prednisone. [8] A 2017 review found its activity of 7.5 mg of deflazacort is approximately equivalent to 25 mg cortisone , 20 mg hydrocortisone , 5 mg of prednisolone or prednisone , 4 mg of methylprednisolone or triamcinolone , or 0.75 mg of betamethasone or dexamethasone .