{"id":1156270,"date":"2026-08-18T20:52:45","date_gmt":"2026-08-18T20:52:45","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/1156270\/"},"modified":"2026-08-18T20:52:45","modified_gmt":"2026-08-18T20:52:45","slug":"lupin-gets-usfda-nod-for-generic-tablets-to-treat-excessive-daytime-sleepiness","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/1156270\/","title":{"rendered":"Lupin gets USFDA nod for generic tablets to treat excessive daytime sleepiness"},"content":{"rendered":"<p>New Delhi: Pharma major <a ref=\"dofollow\" data-ga-onclick=\"Inarticle articleshow link click#Industry#href\" href=\"https:\/\/m.economictimes.com\/topic\/lupin-ltd\" target=\"_blank\" rel=\"nofollow noopener\">Lupin Ltd<\/a> on Monday said it has received final approval from the US health regulator for the generic version of <a ref=\"dofollow\" data-ga-onclick=\"Inarticle articleshow link click#Industry#href\" href=\"https:\/\/m.economictimes.com\/topic\/pitolisant\" target=\"_blank\" rel=\"nofollow noopener\">Pitolisant<\/a> tablets indicated to treat <a ref=\"dofollow\" data-ga-onclick=\"Inarticle articleshow link click#Industry#href\" href=\"https:\/\/m.economictimes.com\/topic\/excessive-daytime-sleepiness\" target=\"_blank\" rel=\"nofollow noopener\">excessive daytime sleepiness<\/a>.<\/p>\n<p>The approval by the <a ref=\"dofollow\" data-ga-onclick=\"Inarticle articleshow link click#Industry#href\" href=\"https:\/\/m.economictimes.com\/topic\/us-food-and-drug-administration\" target=\"_blank\" rel=\"nofollow noopener\">US Food and Drug Administration<\/a> (<a ref=\"dofollow\" data-ga-onclick=\"Inarticle articleshow link click#Industry#href\" href=\"https:\/\/m.economictimes.com\/topic\/usfda\" target=\"_blank\" rel=\"nofollow noopener\">USFDA<\/a>) is for the abbreviated new drug application for Pitolisant Tablets of strengths 4.45 mg and 17.8 mg, <a ref=\"dofollow\" data-ga-onclick=\"Inarticle articleshow link click#Industry#href\" target=\"_blank\" href=\"https:\/\/economictimes.indiatimes.com\/lupin-ltd\/stocks\/companyid-10743.cms\" rel=\"nofollow noopener\">Lupin<\/a> Ltd said in a regulatory filing.<\/p>\n<p><b>Also read: <a data-ga-onclick=\"Inarticle articleshow link click#Industry#href\" href=\"https:\/\/economictimes.indiatimes.com\/industry\/healthcare\/biotech\/pharmaceuticals\/aurobindo-pharmas-raleigh-plant-gets-voluntary-action-indicated-classification-from-us-fda\/articleshow\/133285791.cms\" target=\"_blank\" rel=\"nofollow noopener\">Aurobindo Pharma\u2019s Raleigh plant gets &#8216;Voluntary Action Indicated&#8217; classification from US FDA<\/a><\/b><br \/>The USFDA has approved Lupin&#8217;s Pitolisant tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix, the company said.<\/p>\n<p>Wakix is a prescription medicine used to treat excessive daytime sleepiness (EDS) of <a ref=\"dofollow\" data-ga-onclick=\"Inarticle articleshow link click#Industry#href\" href=\"https:\/\/m.economictimes.com\/topic\/harmony-biosciences\" target=\"_blank\" rel=\"nofollow noopener\">Harmony Biosciences<\/a>.<\/p>\n<p>Add <img decoding=\"async\" alt=\"ET Logo\" src=\"https:\/\/www.europesays.com\/uk\/wp-content\/uploads\/2025\/08\/123467569.cms.png\"\/> as a Reliable and Trusted News Source<br \/>(You can now subscribe to our <a rel=\"nofollow noopener\" href=\"https:\/\/www.whatsapp.com\/channel\/0029Vb6dOI1EKyZPPqpH7I0y\" target=\"_blank\" data-ga-onclick=\"WhtsApChnl#Click_Web#Industry\">Economic Times WhatsApp channel<\/a>)<\/p>\n","protected":false},"excerpt":{"rendered":"New Delhi: Pharma major Lupin Ltd on Monday said it has received final approval from the US health&hellip;\n","protected":false},"author":2,"featured_media":1156271,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[4315],"tags":[314415,314414,151036,105,84224,314416,4326,314413,16,15,205377,88560],"class_list":["post-1156270","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-excessive-daytime-sleepiness","tag-generic-tablets","tag-harmony-biosciences","tag-health","tag-lupin","tag-lupin-ltd","tag-medication","tag-pitolisant","tag-uk","tag-united-kingdom","tag-us-food-and-drug-administration","tag-usfda"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/117118497408916099","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/1156270","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=1156270"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/1156270\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/1156271"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=1156270"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=1156270"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=1156270"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}