{"id":267,"date":"2020-02-10T10:03:00","date_gmt":"2020-02-10T10:03:00","guid":{"rendered":"http:\/\/plethorathemes.com\/healthx\/?p=267"},"modified":"2020-02-16T17:10:11","modified_gmt":"2020-02-16T17:10:11","slug":"novel-drug-approvals-for-2020","status":"publish","type":"post","link":"https:\/\/nutra-medics.com\/index.php\/2020\/02\/10\/novel-drug-approvals-for-2020\/","title":{"rendered":"Novel Drug Approvals for 2020"},"content":{"rendered":"<div class=\"articleContent afp\">\n<div class=\"afpContent\">\n<div class=\"inset-column\">\n<p>and therapeutic biological products, FDA\u2019s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice needed to bring new therapies to market.<\/p>\n<\/div>\n<p>The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.<\/p>\n<p>Each year, CDER approves a wide range of new drugs and biological products:<\/p>\n<ul>\n<li>Some of these products are innovative new products that never&nbsp;have been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2020. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2020 by the&nbsp;<a title=\"Biological Approvals by Year\" href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/development-approval-process-cber\/biological-approvals-year\" data-entity-substitution=\"canonical\" data-entity-type=\"node\" data-entity-uuid=\"065c3693-2add-4aa5-96b7-6de0eba8711c\">Center for Biologics Evaluation and Research<\/a>.<\/li>\n<li>Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See&nbsp;<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/\">Drugs@FDA<\/a>&nbsp;for information about all of CDER\u2019s approved drugs and biological products.<\/li>\n<\/ul>\n<p>Certain drugs are classified as new molecular entities (\u201cNMEs\u201d) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA\u2019s classification of a drug as an \u201cNME\u201d for review purposes is distinct from FDA\u2019s determination of whether a drug product is a \u201cnew chemical entity\u201d or \u201cNCE\u201d within the meaning of the Federal Food, Drug, and Cosmetic Act.<\/p>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered table-striped\" border=\"1\" summary=\"2020 Novel Drugs\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr>\n<th id=\"header1\" scope=\"col\">No.<\/th>\n<th id=\"header2\" scope=\"col\">Drug Name<\/th>\n<th id=\"header3\" scope=\"col\">Active Ingredient<\/th>\n<th id=\"header4\" scope=\"col\">Approval Date<\/th>\n<th id=\"header5\" scope=\"col\">FDA-approved use on approval date*<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>4.<\/td>\n<td><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=overview.process&amp;varApplNo=211281\">Pizensy<\/a><\/td>\n<td>\n<p align=\"LEFT\">lactitol<\/p>\n<\/td>\n<td>2\/12\/2020<\/td>\n<td>To treat chronic idiopathic constipation (CIC) in adults<\/td>\n<\/tr>\n<tr>\n<td>3.<\/td>\n<td><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=overview.process&amp;varApplNo=211723\">Tazverik<\/a><\/td>\n<td>tazemetostat<\/td>\n<td>1\/23\/2020<\/td>\n<td>To treat epithelioid sarcoma<br \/>\n<a title=\"FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-treatment-option-specifically-patients-epithelioid-sarcoma-rare-soft-tissue\" data-entity-substitution=\"canonical\" data-entity-type=\"node\" data-entity-uuid=\"4adc4d37-a803-40d7-a34b-48b93acb09e9\">Press Release<\/a><br \/>\n<a title=\"Drug Trials Snapshots: TAZVERIK\" href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/drug-trials-snapshots-tazverik\" data-entity-substitution=\"canonical\" data-entity-type=\"node\" data-entity-uuid=\"e9455e02-7a6a-4756-9d5e-0256da0c8274\">Drug Trials Snapshot<\/a><\/td>\n<\/tr>\n<tr>\n<td>2.<\/td>\n<td><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=overview.process&amp;varApplNo=761143\">Tepezza<\/a><\/td>\n<td>teprotumumab-trbw<\/td>\n<td>1\/21\/2020<\/td>\n<td>To treat Thyroid eye disease<br \/>\n<a title=\"FDA approves first treatment for thyroid eye disease \" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-treatment-thyroid-eye-disease\" data-entity-substitution=\"canonical\" data-entity-type=\"node\" data-entity-uuid=\"8c8835b3-c8a0-446a-908f-2d95dbc3f7fa\">Press Release<\/a><br \/>\n<a title=\"Drug Trial Snapshot: TEPEZZA\" href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/drug-trial-snapshot-tepezza\" data-entity-substitution=\"canonical\" data-entity-type=\"node\" data-entity-uuid=\"f4f6acd5-8ff6-4a78-8437-5f1a9a5aee3b\">Drug Trials Snapshot<\/a><\/td>\n<\/tr>\n<tr>\n<td>1.<\/td>\n<td><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=overview.process&amp;varApplNo=212608\">Ayvakit<\/a><\/td>\n<td>avapritinib<\/td>\n<td>1\/9\/2020<\/td>\n<td>To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST)<br \/>\n<a title=\"Drug Trial Snapshot: AYVAKIT\" href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/drug-trial-snapshot-ayvakit\" data-entity-substitution=\"canonical\" data-entity-type=\"node\" data-entity-uuid=\"ee9ff5cd-6d27-423f-8d32-4c1d53d5b7ae\">Drug Trials Snapshot<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><small>*The listed \u201cFDA-approved use\u201d on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s),&nbsp;population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information (click on the Drug Name).<\/small><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>and therapeutic biological products, FDA\u2019s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3677,"comment_status":"closed","ping_status":"open","sticky":true,"template":"","format":"standard","meta":[],"categories":[19],"tags":[],"_links":{"self":[{"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/posts\/267"}],"collection":[{"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/comments?post=267"}],"version-history":[{"count":3,"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/posts\/267\/revisions"}],"predecessor-version":[{"id":3684,"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/posts\/267\/revisions\/3684"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/media\/3677"}],"wp:attachment":[{"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/media?parent=267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/categories?post=267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nutra-medics.com\/index.php\/wp-json\/wp\/v2\/tags?post=267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}