{"id":112236,"date":"2024-09-05T00:00:00","date_gmt":"2024-09-05T00:00:00","guid":{"rendered":"https:\/\/medgoo.com\/index.php\/2024\/09\/05\/amid-shortages-u-s-allows-expanded-production-of-adhd-drug-vyvanse\/"},"modified":"2024-09-05T00:00:00","modified_gmt":"2024-09-05T00:00:00","slug":"amid-shortages-u-s-allows-expanded-production-of-adhd-drug-vyvanse","status":"publish","type":"post","link":"https:\/\/medgoo.com\/index.php\/2024\/09\/05\/amid-shortages-u-s-allows-expanded-production-of-adhd-drug-vyvanse\/","title":{"rendered":"Amid Shortages, U.S. Allows Expanded Production of ADHD Drug Vyvanse"},"content":{"rendered":"<h3><\/h3>\n<p><b>By Robin Foster HealthDay Reporter<\/b><\/p>\n<p><b><\/b><\/p>\n<p>THURSDAY, Sept. 5, 2024 (HealthDay News) &#8212; The maker of the ADHD drug Vyvanse has been given approval by the U.S. Drug Enforcement Administration to make more of the medication as a shortage of the  critical drugs continues.<\/p>\n<p>Following a <a href=\"https:\/\/www.healthday.com\/health-news\/child-health\/adhd-2662677272.html\">request<\/a> from the U.S. Food and Drug Administration in July, the DEA said Thursday that Takeda Pharmaceuticals may now increase its production limit by 24%.<\/p>\n<p>\u00e2\u0080\u009cThese adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine [Vyvanse] to meet legitimate patient needs both domestically and globally,\u00e2\u0080\u009d the DEA said in a <a href=\"https:\/\/www.federalregister.gov\/documents\/2024\/09\/05\/2024-20114\/adjustment-to-the-aggregate-production-quota-for-lisdexamfetamine-and-d-amphetamine-for-conversion\">notice<\/a> it posted on the approval.<\/p>\n<p>ADHD drugs have been in short supply\u00a0for years. The\u00a0FDA\u00a0first <a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-announces-shortage-adderall#:~:text=On%20October%2012%2C%202022%2C%20FDA,on%20our%20drug%20shortage%20website.\">warned<\/a> of a shortage of Teva Pharmaceutical Industries\u00e2\u0080\u0099\u00a0Adderall medication in October 2022, as the company was plagued by manufacturing delays.<\/p>\n<p>That prompted a spike in demand and subsequent shortage of Takeda\u00e2\u0080\u0099s Vyvanse.<\/p>\n<p>Why was the DEA&#8217;s approval to boost production needed? <a href=\"https:\/\/www.drugs.com\/vyvanse.html\">Vyvanse<\/a> (lisdexamfetamine) is classified by the DEA as a schedule II controlled substance, which is applied to drugs considered to have a high likelihood of being abused, so additional prescribing safeguards are put in place.<\/p>\n<p>The production limit for lisdexamfetamine was increased by 13,478 pounds (6,236 kilograms), which includes 3,434 pounds (1,558 kg) to address domestic demand and 10,313 pounds (4,678 kg) for foreign demand for finished dosage medications, according to the DEA.<\/p>\n<p>After Takeda lost exclusivity of Vyvanse last year, the FDA <a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-approves-multiple-generics-adhd-and-bed-treatment#:~:text=FDA%20has%20approved%20several%20first,information%20for%20details%20on%20dosing.\">approved<\/a> generic versions of Vyvanse from 11 drugmakers, including U.S.-based drugmakers Mallinckrodt and Viatris, UK-based Hikma Pharmaceuticals and Indian drugmaker Sun Pharmaceutical Industries, <em>Reuters<\/em> reported.<\/p>\n<p><strong>More information<\/strong><\/p>\n<p>The American Academy of Pediatrics has advice for parents on the <a href=\"https:\/\/www.healthychildren.org\/English\/tips-tools\/ask-the-pediatrician\/Pages\/what-should-I-do-if-my-childs-ADHD-medication-is-out-of-stock-during-the-ongoing-shortage.aspx\">ADHD drug shortage<\/a>.<\/p>\n<p>SOURCES: U.S. Drug Enforcement Administration, notice, Sept. 4, 2024; <em>Reuters<\/em><\/p>\n<p><i><\/i><\/p>\n<p><i>Copyright \u00a9 2024 <a href=\"https:\/\/consumer.healthday.com\/\" target=\"_new\" rel=\"noopener\">HealthDay<\/a>. All rights reserved.<\/i><\/p>\n","protected":false},"excerpt":{"rendered":"<p>By Robin Foster HealthDay Reporter THURSDAY, Sept. 5, 2024 (HealthDay News) &#8212; The maker of the ADHD drug Vyvanse has been given approval by the U.S. Drug Enforcement Administration to make more of the medication as a shortage of the critical drugs continues. Following a request from the U.S. Food and Drug Administration in July, [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":112237,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[11],"class_list":["post-112236","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-news"],"_links":{"self":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts\/112236","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/comments?post=112236"}],"version-history":[{"count":0,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts\/112236\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/media\/112237"}],"wp:attachment":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/media?parent=112236"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/categories?post=112236"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/tags?post=112236"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}